FDA Adverse Event
Malfunction
Summary report: N
TITLE2 COUNTERTORQUE ASSY
MDR report key: 1931887
·
Received November 30, 2010
Report
- Report Number
- 2184052-2010-00050
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Date of Event
- August 18, 2009
- Report Date
- August 18, 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
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THREAD LOCK MATERIAL WAS NOT DETECTED ON THREADS. 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 HAVE MOVED WHICH DOES NOT ALLOW THE HEX DRIVER TO PASS THROUGH THE BARREL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TITLE2 COUNTERTORQUE ASSY | COUNTERTORQUE ASSEMBLY | LXH | ZIMMER SPINE | ET1132-01 | L75118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |