FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 34MM
MDR report key: 2893402
·
Received December 21, 2012
Report
- Report Number
- 9616680-2012-01469
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- November 30, 2012
- Report Date
- November 30, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K092561
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS REVISED FOR A PAINFUL LEFT REJUVENATE HIP AND A PSEUDO TUMOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG TAP PRI MOD NCK 0DEG 34MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 32356402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other| R |