MAUDE Adverse Event Report: SYNTHES USA; CERCLAGE FIXATION

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Tissue Damage (2104); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 11/29/2015

Event Type  Death  

Manufacturer Narrative

This report is for an zipfix/unknown quantity/unknown lot.(other number) udi: unknown part number, udi is unavailable (b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article: kalbe, m., et al (2015).Reconstruction of massive post-sternotomy defects with allogeneic bone graft: four-year results and experience using the method.Interactive cardivascular and thoracic surgery, 1-9.The objective of this study was gain understanding of management of deep sternal wound infections in cardiac surgery.Transplantation of allogenic bone graft occurred in ten patients.In four of these patients, a zipfix was used as the sternal closure.Two transversal two-way malleable titanium plates were used to stabilize the chest wall.In patient 10, the patient fell 23 days after chest wall reconstruction.The plate binding broke loose and injured the soft tissues.Wound revision indicated necessity of removing plates.Wound needed to be revised twice due to hemorrhage of the flap.Infection developed requiring long term vac system treatment.The patient suffered additional complications (gastric ulcer, renal insufficiency) and died of septic complications six months after reconstruction.This is report 1 of 2 for (b)(4).This report is for an unknown zipfix.A copy of the literature article is being submitted with this medwatch.

• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5566759
• MDR Text Key: 42271663
• Report Number: 2520274-2016-11972
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 82 YR