FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1180832
·
Received September 23, 2008
Report
- Report Number
- 1030489-2008-00537
- Event Type
- Malfunction
- Date Received
- September 23, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 25, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE SHEARED OFF DURING USE IN SURGERY. THE BROKEN FRAGMENT WAS LEFT IMPLANTED IN THE PT'S VERTEBRAL BODY. THERE WERE NO PT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | GUIDEWIRE | LXH | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |