FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 34MM
MDR report key: 2911060
·
Received January 4, 2013
Report
- Report Number
- 9616680-2013-90019
- Event Type
- Injury
- Date Received
- January 4, 2013
- Date of Event
- December 14, 2012
- Report Date
- December 14, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K071082
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT STRYKER IMPLANTS WERE REMOVED DUE TO ALTR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4327 | LRG TAP PRI MOD NCK 0DEG 34MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 32662001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |