FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1063018
·
Received June 19, 2008
Report
- Report Number
- 1030489-2008-00287
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Report Date
- May 20, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. 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 2MM PITUITARY TIP WAS BROKEN OFF DURING USE IN SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | PITUITARY | LXH | MEDTRONIC SOFAMOR DANEK | NA | GZ06A058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |