FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
MDR report key: 1973063
·
Received January 28, 2011
Report
- Report Number
- 1030489-2011-00083
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- December 8, 2010
- Report Date
- January 4, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT BROKE DURING USE BUT ALL PARTS OF THE DEVICE WERE RETRIEVED. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING | NA | GZ07D094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |