FDA Adverse Event
Injury
Summary report: N
UNKNOWN REJUVENATE NECK
MDR report key: 2896147
·
Received December 28, 2012
Report
- Report Number
- 9616680-2012-01535
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- December 5, 2012
- Report Date
- December 5, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 PT WAS REVISED DUE TO HIGH ION LEVELS. THIS WAS A LEFT REJUVENATE REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN REJUVENATE NECK | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |