FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1002535
·
Received February 7, 2008
Report
- Report Number
- 1030489-2008-00058
- Event Type
- Malfunction
- Date Received
- February 7, 2008
- Date of Event
- January 3, 2008
- Report Date
- January 9, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVAL. VISUAL EXAMINATION CONFIRMED THAT THE RETAINING PIN HAS SHEARED AND THE SETSCREW IS MISSING. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ILIO SACRAL SCREWDRIVER'S RETAINING SCREW WAS BROKEN. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | SCREWDRIVER | HXX | MEDTRONIC SOFAMOR DANEK | NA | IT06M013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |