FDA Adverse Event
Injury
Summary report: N
TI SPIRAL BLADE 70MM FOR
MDR report key: 2020178
·
Received March 7, 2011
Report
- Report Number
- 8030965-2011-00054
- Event Type
- Injury
- Date Received
- March 7, 2011
- Report Date
- February 18, 2011
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- KTT
- PMA / PMN Number
- K033618
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBJECT DEVICE NOT EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED.
Description of Event or Problem · 1
A DEVICE REPORT RECEIVED INDICATES A PT STATUS POST NAIL AND SPIRAL BLADE IMPLANTATION, DATE UNK, RETURNED TO SURGEON, DATE UNK. IT WAS DISCOVERED THE SPIRAL BLADE BECAME LOOSE IN THE NAIL. IT WAS NOTED STABILITY WAS ENSURED AS A ANGULAR STABLE LOCKING SYSTEM WAS USED FOR THE PROXIMAL SCREW. THE PRODUCT WAS NOT REMOVED. THIS IS ONE OF TWO REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI SPIRAL BLADE 70MM FOR | SPIRAL BLADES | KTT | SYNTHES ELMIRA | NA | 6426513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |