FDA Adverse Event
Injury
Summary report: N
SMART TOE
MDR report key: 2588141
·
Received May 8, 2012
Report
- Report Number
- 3004082045-2012-00002
- Event Type
- Injury
- Date Received
- May 8, 2012
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- MEMOMETAL TECHNOLOGIES SA BRUZ
- Product Code
- KWH
- PMA / PMN Number
- K070598
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVAL. ADD'L INFO WAS REQUESTED BUT NOT RECEIVED. IF THE DEVICE OR ADD'L INFO IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. AS INSTRUCTED BY (B)(6) ON (B)(6) 2011, MDR REPORTED BY MEMOMETAL TECHNOLOGIES/(B)(4) AS A RESULT OF A RETROSPECTIVE LOOK BACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF MEMOMETAL TECHNOLOGIES BY (B)(6).
Description of Event or Problem · 1
AFTER THE SURGERY, IMPLANT HAS BROKEN IN THE PT'S FOOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART TOE | IMPLANT | KWH | MEMOMETAL TECHNOLOGIES SA BRUZ | NA | 0006484Q18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |