FDA Adverse Event
Other
Summary report: N
ZNN CMN LAG SCREW 10.5X115
MDR report key: 1809776
·
Received August 10, 2010
Report
- Report Number
- 9613350-2010-00383
- Event Type
- Other
- Date Received
- August 10, 2010
- Date of Event
- July 20, 2010
- Report Date
- July 23, 2010
- Manufacturer
- ZIMMER GMBH
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICE IN THE U.S. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE ALLEGED DEVICE WILL BE SENT BACK TO ZIMMER LABS FOR INVESTIGATION. AS SOON AS THE INVESTIGATION RESULTS ARE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. (B)(4).
Description of Event or Problem · 1
IT IS REPORTED THAT THE HEAD OF THE LAG SCREW BROKE WHILE TRYING TO EXTRACT. THE SURGERY WAS PROLONGED FOR 2 HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZNN CMN LAG SCREW 10.5X115 | ZIMMER UNIVERSAL LOCKING SYSTEM | HWC | ZIMMER GMBH | NA | 2510839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |