FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 34MM
MDR report key: 2885222
·
Received December 18, 2012
Report
- Report Number
- 9616680-2012-01431
- Event Type
- Injury
- Date Received
- December 18, 2012
- Date of Event
- November 28, 2012
- Report Date
- November 28, 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION(INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT WAS HAVING PAIN, ELEVATED COBALT LEVELS SO PT WAS REVISED.
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 | 32904702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |