2520274-2013-11031
Report
- Report Number
- 2520274-2013-11031
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- April 27, 2012
- Report Date
- May 1, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- MNI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4).
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON AN UNKNOWN DATE WITH THE MATRIX CONSTRUCT. THE PATIENT WAS RETURNED TO THE OR FOR A REVISION SURGERY BECAUSE A SCREW WAS IN THE WRONG POSITION AND REQUIRED REPLACEMENT AND REPOSITIONING. THE SURGEON WAS UNABLE TO REMOVE THE LOCKING CAPS AND REPOSITION THE SCREW. IT WAS NOTED THAT THE LOCKING CAPS WERE COLD WELDED TO THE SCREW. THE SURGEON HAD TO CUT AND REMOVE THE ROD, THEN REMOVED TWO SCREWS AND LOCKING CAPS. IT IS NOT KNOWN WHAT THE PATIENT WAS REVISED TO. THIS IS REPORT 3 OF 6 FOR THIS EVENT. THIS REPORT IS ON THE ROD.
THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125552 | MNI | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |