FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT - SMART TOE
MDR report key: 2445715
·
Received February 7, 2012
Report
- Report Number
- 8031020-2012-00046
- Event Type
- Injury
- Date Received
- February 7, 2012
- Date of Event
- January 5, 2012
- Report Date
- January 23, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZAC
- Product Code
- KWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE SALES REP THAT: "ONE OF MY SURGEONS HAD DECIDED TO STOP USING THE STO DUE TO EXCESSIVE REVISIONS DUE TO NON FUSION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT - SMART TOE | IMPLANT | KWH | STRYKER OSTEOSYNTHESIS SELZAC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |