FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 2000884
·
Received February 24, 2011
Report
- Report Number
- 1030489-2011-00196
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 26, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DRIVER WAS RETURNED FOR EVALUATION. VISUAL AND OPTICAL EXAMINATION REVEALS APPROXIMATELY ~3MM OF TIP HAS BEEN BROKEN OFF, CO NSISTENT WITH INTERFACE DURING USAGE. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT, BRITTLE FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHILE TIGHTENING A SET SCREW. THE TIP OF THE DRIVER WAS RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING | NA | SA10G006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SET SCREW |