FDA Adverse Event
Injury
Summary report: N
SMART TOE
MDR report key: 2622483
·
Received June 14, 2012
Report
- Report Number
- 8031020-2012-00134
- Event Type
- Injury
- Date Received
- June 14, 2012
- Date of Event
- May 29, 2012
- Report Date
- May 30, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HTY
- PMA / PMN Number
- K070598
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT IS NOT KNOWN AT THIS TIME IF THE PT WILL BE REVISED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
AN MMI SMART TWO IMPLANT BROKE AFTER IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART TOE | IMPLANT | HTY | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |