FDA Adverse Event
Malfunction
Summary report: N
TITLE2 COUNTERTORQUE ASSEMBLY
MDR report key: 1931970
·
Received November 30, 2010
Report
- Report Number
- 2184052-2010-00046
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Date of Event
- June 19, 2009
- Report Date
- June 19, 2009
- Manufacturer
- ZIMMER SPINE
- Product Code
- LXH
- Removal / Correction Number
- 2184052-10/6/2010-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS: THREAD LOCK MATERIAL WAS NOT DETECTED ON THREADS. CONCLUSIONS: THREADED BALL PLUNGER WAS NOT ASSEMBLED WITH THREAD LOCK. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE.
Description of Event or Problem · 1
DURING KIT INSPECTION, THE THREADED BALL PLUNGER WAS FOUND TO BE MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TITLE2 COUNTERTORQUE ASSEMBLY | COUNTERTORQUE ASSEMBLY | LXH | ZIMMER SPINE | ET1132-01 | L75118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |