Complications Matter

Sternotomy | Sternum Surgery Complications

Complications Matter

Information presented is a sumary of study results and should not be construed as a substitute for reviewing the actual study itself. All results are comparisons to wire closure.1

Sternal stability and healing plays a key role in reducing the risk of sternal complications, including deep and superficial sternal wound infections. In the SternaLock Blu Study, all sternal complications out to six months were evaluated, as they are significant clinical and economic events.

At six months, the overall sternal complication rate was 0% in patients treated with SternaLock Blu and 5% in patients treated with wire cerclage. These sternal complications resulted in multiple readmissions, 11 reoperations, and an additional 94 days of hospital stay. An analysis of risk factors for sternal complications revealed that the only predictor of sternal complications in this study was the method of sternal closure, and patients closed with wire cerclage were 11.5x more likely to have a sternal complication than SternaLock Blu patients.

Patients treated with SternaLock Blu experienced fewer sternal complications.1

Sternotomy - Sternal Complications
Sternotomy - Sternal Complications
Sternotomy - Sternal Complications
Sternotomy - Sternal Complications
Sternotomy - Sternal Complications
Sternotomy - Sternal Complications
Sternotomy - Sternal Complications
Sternal Closure - Predictors of Sternal Healing
Sternotomy - Sternal Complications
Sternal Closure - Predictors of Sternal Healing

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RISK INFORMATIONSternaLock Blu
SternaLock 360

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SternaLock Blu

Patient Risk Information

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INDICATIONS

The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion.

CONTRAINDICATIONS

  1. Active infection
  2. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
  3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

Download Complete SternaLock Blu IFU (pdf)

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SternaLock 360

Patient Risk Information

Download PDF

INDICATIONS

The SternaLock 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

CONTRAINDICATIONS

  1. Active infection
  2. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
  3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

Download Complete SternaLock 360 IFU (pdf)

1 CR 0712S (Clinical Study Report) SternaLock Blu Study, 2014-15, an evaluation of rigid plate fixation in supporting bone healing: a prospective, multi-center trial of 236 total patients undergoing full midline sternotomy.