MAUDE Adverse Event Report: SYNTHES (USA); PROSTHESIS, RIB REPLACEMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: ¿acellular dermal matrix in the treatment and prevention of exposed vertical expandable prosthetic titanium ribs".Between january 2002 and january 2010, eight patients who underwent placement of acellular dermal matrix (adm) for the treatment and prevention of exposed vertical expandable prosthetic titanium rib (veptr) devices were identified.One of the patients, with soft tissue breakdown and veptr exposure presented with an active infection.Despite aggressive wound management, intravenous antibiotics, and soft tissue closure with adm, stable soft tissue coverage was not attained and subsequent hardware removal was required.In this case, overly prominent hardware was additionally felt to contribute to the overall lack of success.This is report 1 of 1 for (b)(4), for infection and device removal.The patient is identified in the article as ¿(b)(6)¿, is female and was (b)(6) old, and was noted to have undergone 10 expansions pre-adm.

Manufacturer Narrative

Spine 2011, volume 36, number 8, ppe563-e567.This report is for 1 unknown veptr construct.Gill, r.Et al (2011).¿acellular dermal matrix in the treatment and prevention of exposed vertical expandable prosthetic titanium ribs¿.Spine, volume 36, pp e563-e567.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES (USA)
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3768242
• MDR Text Key: 15105672
• Report Number: 2520274-2014-10991
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2014
• 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): Required Intervention
• Patient Age: 5 YR