FDA Adverse Event
Malfunction
Summary report: N
TRINICA CERVICAL PLATE SYSTEM
MDR report key: 1082180
·
Received July 22, 2008
Report
- Report Number
- 2184052-2008-00020
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 25, 2008
- Report Date
- June 26, 2008
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DIMENSIONAL ANALYSIS AND REVIEW OF THE BATCH RECORDS: DIMENSIONAL ANALYSIS DID NOT REVEAL ANY DISCREPANCIES. BATCH RECORD REVIEW CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO ALL APPLICABLE SPECS.
Description of Event or Problem · 1
DURING SURGERY ONE DRILL GUIDE TUBE DETACHED FROM THE INSTRUMENT. THE BROKEN PIECE WAS RETRIEVED. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRINICA CERVICAL PLATE SYSTEM | ATO VARIABLE DRILL GUIDE | LXH | ZIMMER SPINE, INC. | 07.00782.001 | P040131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |