FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 34MM
MDR report key: 2896194
·
Received December 28, 2012
Report
- Report Number
- 9616680-2012-01520
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- December 12, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K071082
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT SURGEON WILL BE REVISING PT'S LEFT REJUVENATE STEM DUE TO METALOSIS. SURGERY SCHEDULED FOR (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG TAP PRI MOD NCK 0DEG 34MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | 35367901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |