FDA Adverse Event
Malfunction
Summary report: N
BAK/C CERVICAL INTERBODY
MDR report key: 1031916
·
Received April 16, 2008
Report
- Report Number
- 2184052-2008-00012
- Event Type
- Malfunction
- Date Received
- April 16, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 18, 2008
- Manufacturer
- ZIMMER SPINE, INC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL - NO DEVICE HISTORY RECORD DISCREPANCIES. INSTRUMENT WAS MFG TO ALL APPLICABLE SPECS AND REQUIREMENTS. A FOLLOW UP REPORT WILL SENT WHEN THE PT INFO IS PROVIDED.
Description of Event or Problem · 1
SURGERY DATE WAS 2008. DURING SURGERY, ONE OF THE FOUR PRONGS THAT ENGAGES THE IMPLANT BROKE OFF DURING INSERTION. THE BROKEN PRONG WAS REMOVED FROM THE WOUND AND DISPOSED OF BY THE HOSP. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAK/C CERVICAL INTERBODY | IMPLANT DRIVER | LXH | ZIMMER SPINE, INC | 6200-0022-00 | P010241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |