Universal Clamp^® Spinal Fixation System

INDICATIONS – FOR USA ONLY

The Universal Clamp Spinal Fixation System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Universal Clamp System may also be used in conjunction with other medical grade implants made of similar metals whenever “wiring” may help secure the attachment of the other implants.

INDICATIONS – FOR OUTSIDE USA

The Universal Clamp Spinal Fixation System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis, kyphosis and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Universal Clamp System may also be used in conjunction with other medical grade implants made of similar metals whenever “wiring” may help secure the attachment of the other implants.

The Universal Clamp System is not designed or sold for any use except as indicated. Do not use Universal Clamp implants in the presence of any contraindications.

Contraindications include, but are not limited to:

1. Active systemic infection, or infection localized to the site of the proposed implantation, are contraindications to implantation.
2. Severe osteoporosis is a contraindication because it may prevent adequate fixation.
3. Suspected or documented metal allergy or intolerance.
4. Inadequate tissue coverage over the operative site.
5. In any situation where implant utilization would interfere with anatomical structures or expected physiological performance, such as impinging on vital structures.
6. Severe fractures such that segments may not be maintained in satisfactory proximate reduction.
7. Any entity or condition that compromises the possibility of fusion, i.e. such as cancer, kidney dialysis or osteopenia.
8. Other relative contraindications include obesity, pregnancy, certain degenerative disease, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, some patients may, because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism or drug abuse, place undue stresses on the implant.

Following are specific warnings, precautions, and adverse effects associated with use of the Universal Clamp System that should be understood by the surgeon and explained to the patients. General surgical risk should be explained to the patients prior to surgery.

• Implantation should be performed only by experienced spinal surgeons
• All implants are intended for single use only. Single use devices should never be re‑used or re‑sterilized. Possible risks associated with re‑use of or re‑sterilization of single‑use devices include:
  • Mechanical malfunction
  • Transmission of infectious agents
• Metal sensitivity has been reported following exposure to orthopedic implants. The most common metals associated with metal sensitivities (nickel, cobalt, and chromium) are present in medical grade stainless steel and cobalt‑chrome alloys.
• After solid fusion occurs, this device serves no functional purpose and may be removed. In most cases, removal is indicated because the implant is not intended to transfer or support forces developed during normal activities after several months. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient’s general medical condition and the potential risk to the patient of a second surgical procedure.
• Implants can break when subjected to the prolonged loading associated with delayed union or non‑union. Internal fixation systems are load sharing devices that are used to obtain alignment until normal healing occurs. If healing is delayed or does not occur, the implant may eventually fail. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Patients should be fully informed of the risks of implant failure.
• Universal precautions should be observed by all end users that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges to prevent injuries during and after surgical procedures and reprocessing.

Additional preoperative, intraoperative, and postoperative warnings and precautions:

PREOPERATIVE

• Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct; otherwise, galvanic corrosion may occur.

INTRAOPERATIVE

• Insertion of an implant must be done using the instruments designed and supplied for this purpose and the technique specific to each device. The details of this insertion are found in the Universal Clamp System Surgical Technique supplied by Zimmer Biomet Spine.
• Bone integrity should be verified. Osteoporosis or any other bone tissue diseases that may alter the mechanical properties of the vertebrae must be taken into account when deciding whether to insert a Zimmer Biomet Spine Universal Clamp System.
• Elevators and band passers should not be used for sublaminar passage. They should only be used for passage around the transverse process.
• Be sure to follow the markings on the reduction instrument. Going beyond the markings and forced use may result in excessive tension and, depending on bone quality, bony fracture.
• Be sure to insert the band in the right direction in the Universal Clamp implant clamp, as indicated by an arrow engraved on the upper jaw of the clamp.
• Be sure to follow the instructions for preparing the loop. The woven band that makes up the loop is attached using the metal buckles, as described in the Surgical Technique.
• Be sure to place the Universal Clamp implant properly on compatible rod by verifying that the arrow engraved on the clamp is visible and pointing toward the mid‑line of the spinal column.
• Be sure not to over‑tighten the Universal Clamp implant’s locking screw prior to performing reduction or compression/distraction maneuvers. Over‑tightening reduces compression/ detraction capabilities and increases the risk of damage to the band. Two tightening turns are sufficient prior to compression/distraction.
• Be sure not to over‑tighten the Locking Screw using the locking screw holder. The end of the locking screw holder may cause damage to the imprint of the locking screw head.
• Be sure to avoid any risks of sepsis related to the band. Bands may be placed in a sterile plastic bags placed bilaterally along the incision. Be sure to firmly tighten the Universal Clamp implant locking screw. Only use the Final Screwdriver for final tightening, as this driver is not tapered at the tip.
• Ensure Final Screwdriver is axially aligned with the Universal Clamp locking screw during final tightening of the implant.
• Additional fixation is required at the cephalad and caudal ends of the construct in scoliosis surgery, especially in case of obesity, extreme kyphosis or muscular weakness, except where additional fixation would increase the risk to the patient.
• If any implant or instrument comes in contact with a non‑sterile surface it should not be used.

POSTOPERATIVE

• Adequately instruct the patient. Postoperative care and the patient’s ability and willingness to follow instructions are one of the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in fracture. The patient should understand that an implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing. An active, debilitated, or demented patient who cannot properly use weight‑supporting devices may be particularly at risk during postoperative rehabilitation.

1. Non-union, delayed union
2. Disassembly, fraying, kinking, loosening, bending or breakage of any or all of the UNIVERSAL CLAMP System implant components
3. Metal sensitivity, polyester sensitivity or allergic reaction to a foreign body
4. Infection
5. Foreign body reaction to the implants including possible tumor formation
6. Pain, discomfort, or abnormal sensations due to the presence of the device
7. Pressure on the skin from component parts, where there is inadequate tissue coverage over the implant causing skin irritation
8. Loss of proper spinal curvature, correction height and/or reduction
9. Implants cutting through soft osteoliorotic, osteolienic or cancellous bone
10. Bone forming around the impant making removal difficult or impossible
11. Cessation of growth in the operrated portion of bone
12. Decrease in bone density due to stress shielding
13. Vascular and/or nerve damage due to surgical trauma or presence of the device. Neurological difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation, and paraesthesia
14. Bursitis
15. Dural leak
16. Paralysis
17. Death
18. Erosion of blood vessels due to the proximity of the device, leading to hemorrhage and/or death