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

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Exact age/date of birth is unknown; reported as being (b)(6).The 510k: this report is for an unknown veptr rib hook/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient who had been implanted with a unilateral vertical expandable prosthetic titanium rib (veptr ii) system on an unknown date, underwent a simple veptr distraction on (b)(6) 2017.However, it was known preoperatively that the rib hook had pulled loose.The surgeon replaced the rib hook, extended it another level from t4 to t3 with a rib hook extension and replaced the proximal extension.It was reported that the final x-ray confirmed good fixation.The surgery was completed successfully and the patient was reported as stable.Concomitant devices: veptr rib hook extension (quantity 1), veptr proximal extension (quantity 1).This report is for an unknown veptr rib hook.This is report 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6279369
• MDR Text Key: 65832163
• Report Number: 2520274-2017-10287
• Device Sequence Number: 1
• Product Code: MDI
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2017
• 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
• Treatment: ONE UNKNOWN VEPTR PROXIMAL EXTENSION; ONE UNKNOWN VEPTR RIB HOOK EXTENSION
• Patient Outcome(s): Required Intervention