FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURICAL INSTRUMENT
MDR report key: 1181754
·
Received September 18, 2008
Report
- Report Number
- 1030489-2008-00524
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Report Date
- August 20, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION FOUND THAT THE DYNAMIC SHAFT IS BROKEN AT THE PIN HOLE LOCATION, SUGGESTING EXCESSIVE FORCE APPLIED TO THE HANDLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE MICROPITUITARY WAS BROKEN DURING USE IN SURGERY. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURICAL INSTRUMENT | MICROPITUITARY | LXH | MEDTRONIC SOFAMOR DANEK | NA | GZ06B039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |