FDA Adverse Event
Injury
Summary report: N
SMART TOE ANGLED 16MM
MDR report key: 2221610
·
Received August 19, 2011
Report
- Report Number
- 3004082045-2011-00002
- Event Type
- Injury
- Date Received
- August 19, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 1, 2011
- Manufacturer
- MEMOMETAL TECHNOLOGIES SA
- Product Code
- HTY
- PMA / PMN Number
- K070598
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IT WAS INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL AS IT IS STILL IMPLANTED. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE ORIGINAL SURGERY WAS (B)(6) 2009. THE SMART TOE WAS BROKEN IN THE MIDDLE. THE DISTRIBUTION SAW THE X RAY. THE BREAK WAS RECENT SO MAYBE 18 MONTHS AFTER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART TOE ANGLED 16MM | PLATE | HTY | MEMOMETAL TECHNOLOGIES SA | NA | 08208200753AN47 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other| R |