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Patient Risk Information

What are the risks associated with sternal closure?1

To help minimize risk it is always important to follow your surgeon’s sternal precautions. Sternal Precautions are preventative guidelines provided by your surgeon to protect the breastbone and help reduce complications.

While uncommon, breastbone complications can occur during and after surgery.  Complications include, but are not limited to:

  • Poor bone conditions can cause the plates or screws to fracture
  • Incomplete bone healing or delayed healing
  • Allergic reaction to metal plates and screws
  • Decrease in bone density
  • Shifting, bending, breaking or loosening of plates and screws
  • Pain, discomfort, abnormal sensation, or palpability due to the presence of the plates and screws
  • Inflammation around the fracture site and/or the plates or screws
  • Poor healing of the bone
  • Decomposition of bone
  • Improper selection of screws that are too long for the thickness of the breastbone may protrude to the interior of the chest

Apart from the adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve or soft tissue (non-bone) damage, and pain which may or may not be related to the implant. Implanted metal plates and screws cannot replace normal healthy bone, and the device can break, bend or be damaged as a result of stress, activity, load bearing or inadequate bone healing. Continue regular postoperative follow-up examination as long as the plates and screws remain implanted.

You are not a candidate for sternal plating if you have the following:

  • Current, active infection
  • Specific metal allergy or sensitivities
  • Mental condition preventing compliance with postoperative care instructions
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References

  1. SternaLock Blu IFU 01-50-1215

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The information herein is of a general nature and does not represent or constitute medical advice or recommendations and is for general education purposes only. The information includes descriptions of a medical device that a thoracic (heart) surgeon may choose for patients undergoing open-heart surgery.

Zimmer Biomet manufactures medical devices, including metal plates and screws that may be used by your heart surgeon to hold together the sternum (breastbone) after heart surgery. We do not practice medicine; all questions regarding your medical condition must be directed to your doctor(s).

Results with breastbone (sternum) plates and screws (rigid fixation) will vary due to health, weight, activity and other variables.  Not all patients are candidates for this product and/or procedure.  Only a medical professional can determine the treatment appropriate for your specific condition.  Appropriate post-operative activities will differ from patient to patient.  Talk to your surgeon about whether rigid fixation is right for you and the risks associated therewith, including but not limited to the risks of infection, implant wear, loosening, screw or plate breakage or incomplete bone healing. For a complete list of risks associated with Zimmer Biomet’s rigid fixation system, see Patient Risk Information.

The SternaLock Blu study was funded by Zimmer Biomet.

All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet.

©2017 Zimmer Biomet