FDA Adverse Event
Injury
Summary report: N
11.0MM TI HELICAL BLADE 105MM
MDR report key: 1780753
·
Received July 27, 2010
Report
- Report Number
- 1719045-2010-00185
- Event Type
- Injury
- Date Received
- July 27, 2010
- Date of Event
- July 13, 2010
- Report Date
- July 14, 2010
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- KTT
- PMA / PMN Number
- K011857
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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
PATIENT STATUS POST HELICAL BLADE AND NAIL IMPLANTATION RETURNED TO SURGEON FOR OFFICE VISIT. AN X-RAY SHOWED THE HELICAL BLADE HAS CUT OUT TO THE FEMORAL HEAD. SURGEON REMOVED THE HARDWARE AND REVISED TO A LONG TFN AND LAG SCREW. SURGEON NOTED THE FRACTURE WAS HEALED. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 11.0MM TI HELICAL BLADE 105MM | TI HELICAL BLADES | KTT | SYNTHES ELMIRA | NA | 6289532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | NAIL |