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); No Code Available (3191)

Event Date 06/25/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by reporter.This report is for an unknown veptr ii device construct.Part and lot numbers were not provided by reporter.Other: udi# is unavailable.Implant dates of veptr ii construct are (b)(6) 2014 and (b)(6) 2015 for extension.The subject device construct remains implanted in the patient as of the aware date of this report.(b)(6).The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(4).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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the patient who had previously been implanted with veptr ii implants for her progressive scoliosis and severe thoracic deformity experienced post-surgical wound dehiscence on (b)(6) 2015.The patient was hospitalized on (b)(6) 2015 and the wound was surgically debrided and re-sutured on (b)(6) 2015.The patient was released from the hospital after recovery was confirmed on (b)(6) 2015.The surgeon remarked that the wound had become dehiscent because of too much pressure from the patient's veptr ii implants while the patient's skin was still fragile after a previous infection diagnosed and treated (b)(6) 2015.The infection event is addressed and reported separately in related complaint ((b)(4)).This report is for an unknown veptr ii device construct.This report is 1 of 1 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• 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: 5286460
• MDR Text Key: 33193613
• Report Number: 2520274-2015-17777
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• 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?: Yes
• Date Manufacturer Received: 11/19/2015
• 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