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

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr implant/unknown lot.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that dislocation of implant was confirmed; the re-surgery was performed on (b)(6) 2015 for the patient being treated for congenital scoliosis.(b)(6) 2011: initial implant of vertical expandable prosthetic titanium rib (veptr).(b)(6) 2014: the veptr system applied to the patient in left region form the second rib to the fourth lumber with size 13.(b)(6) 2015: a one centimeter extension was noted.(b)(6) 2015: the patient complaint pain in his hip after dancing at a sports festival and diagnosed the possibility of veptr dislocation.(b)(6) 2015: the dislocation of veptr was confirmed at the reporting hospital and the patient was hospitalized.(b)(6) 2015: the re-surgery was performed: the hybrid-typed veptr which had been implanted was removed.Simultaneously, rear osteotomy fixation was performed.The glowing -rod was replaced.It is reported as of (b)(6) 2015 that the patient was doing well.This report is for an unknown veptr implant.This is report 1 of 1 for com-(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: 5021500
• MDR Text Key: 23705607
• Report Number: 2520274-2015-15381
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• 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?: Yes
• Date Manufacturer Received: 08/06/2015
• 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: 10 YR