MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI LUMBAR EXTENSION SIZE 9/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Model Number 497.134

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

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 reports an event in (b)(6) as follows: it was reported that during a spinal procedure performed on (b)(6) 2018; during removal and placement of implants in the [spinal] column, it was observed during the procedure that the patient had metallosis in the spine caused by the [previously implanted] vertical expandable prosthetic titanium rib (veptr) implants documented as a lumbar extension rod and a titanium rib sleeve (or extension bar).Washing and debridement of the soft tissue were performed.Arthrodesis was performed with expedium [growing spine system implants].The surgery was completed without complication.It is unknown if there were additional devices implanted to support the veptr rods.All available information has been reported.This report is for one (1) ti lumbar extension size 9/220mm radius.This is report 1 of 2 for complaint (b)(4).

• Brand Name: TI LUMBAR EXTENSION SIZE 9/220MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7346102
• MDR Text Key: 102710216
• Report Number: 8030965-2018-52160
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 10705034787565
• UDI-Public: (01)10705034787565(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 497.134
• Device Catalogue Number: 497.134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention