FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 38MM
MDR report key: 2896230
·
Received December 28, 2012
Report
- Report Number
- 9616680-2012-01532
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- December 11, 2012
- Report Date
- December 11, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K07182
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, COMPONENTS WERE EXPLANTED DUE TO ADVERSE LOCAL TISSUE REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG TAP PRI MOD NCK 0DEG 38MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | 26963801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other| R |