FDA Adverse Event
Malfunction
Summary report: N
BAK/C
MDR report key: 1485822
·
Received July 28, 2009
Report
- Report Number
- 2184052-2009-00040
- Event Type
- Malfunction
- Date Received
- July 28, 2009
- Date of Event
- November 20, 2006
- Report Date
- November 20, 2006
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY RECORD REVIEWED. REVIEW OF DEVICE HISTORY RECORDS INDICATE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THIS MDR IS BEING SUBMITTED LATE AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES CONDUCTED IN-CONJUNCTION WITH IMPLEMENTATION OF REVISED MDR REPORTING CRITERIA FOR ZIMMER.
Description of Event or Problem · 1
AFTER THE CAGE WAS IMPLANTED, THE SURGEON WENT BACK TO ADVANCE THE CAGE FURTHER BUT DIDN'T ENGAGE THE DRIVER FULLY, AS THE SURGEON ROTATED THE DRIVER ONE OF THE DISTAL TANGS BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. NO ADDITIONAL SURGERY TIME WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAK/C | IMPLANT DRIVER | HXX | ZIMMER SPINE, INC. | 6200-0022-00 | P000590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |