MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PROSTHESIS, RIB REPLACEMENT

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown rod.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant device 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on an unknown date, a surgery was performed using the vertical expandable prosthetic titanium rib ii (veptr ii) system.On (b)(6) 2017, the patient underwent the hardware removal surgery where the implanted s-rod ø6 (unknown left or right) was removed or replaced due to breakage.The hook was broken at its shaft part.The screw heads part of the parallel connector 5.0/6.0 was broken; therefore the driver did not work and the surgeon needed to cut the connector for extraction.It was considered the screw heads were broken during the insertion operation of the implant.The revision surgery was successfully completed.Patient outcome reported as okay.This report is for one (1) unknown rod.This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

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

Further it was clarified that the breakage of the rod and hook was confirmed through an x-ray after initial surgery on an unknown postoperative date.Also, it is unknown whether the screw heads (part of the parallel connector) were broken during initial surgery or not.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7102214
• MDR Text Key: 94344657
• Report Number: 8030965-2017-50479
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 01/11/2018
• 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