FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 8DEG 34MM
MDR report key: 2885178
·
Received December 17, 2012
Report
- Report Number
- 9616680-2012-01426
- Event Type
- Injury
- Date Received
- December 17, 2012
- Date of Event
- February 10, 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
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN 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: "THE PT STARTED HAVING PAIN AND ISSUES WITH FLEXION AS WELL AS GOING UP STAIRS AND GETTING UP FROM A SITTING POSITION MOST SEVERELY IN (B)(6) 2012. SHE IS HAVING CONSTANT PAIN AND DIFFICULTY SLEEPING. SHE IS SCHEDULED FOR A REVISION ON (B)(6) 2012." ADDITIONAL INFO REPORTED VIA SALES REP (B)(6) 2012: IT WAS REPORTED THAT THE PT HAD ADVERSE LOCAL TISSUE REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG TAP PRI MOD NCK 8DEG 34MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 32987701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |