FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 8DEG 42MM
MDR report key: 2869629
·
Received November 30, 2012
Report
- Report Number
- 9616680-2012-01252
- Event Type
- Injury
- Date Received
- November 30, 2012
- Date of Event
- January 25, 2011
- Report Date
- November 8, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K092561
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
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 IS EXPERIENCING ABRASIONS ON HIS ANKLE. PT ALSO STATES THAT PT IS EXPERIENCING SOME PAIN. PT IS REPORTING THAT HE CANNOT SLEEP IN HIS BED AND THAT CURRENTLY HE SLEEPS IN A LA-Z BOY RECLINER. PT IS ALSO REPORTING THAT HE WALKS WITH A CANE. PT IS STATING THAT HIS WHOLE LEG IS DISCOLORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG TAP PRI MOD NCK 8DEG 42MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | 31842402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |