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

Model Number	497.134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7346102
• Report Number: 8030965-2018-52160
• Device Sequence Number: 554914
• Product Code: MDI
• UDI-Device Identifier: 10705034787565
• UDI-Public: (01)10705034787565(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 497.134
• Device Catalogue Number: 497.134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention