FDA Adverse Event
Injury
Summary report: N
PFNA BLADE L95 TAN
MDR report key: 2243846
·
Received September 7, 2011
Report
- Report Number
- 8030965-2011-00596
- Event Type
- Injury
- Date Received
- September 7, 2011
- Report Date
- August 10, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- KTT
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT DISTRIBUTED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
DEVICE REPORT FROM (B)(6) INDICATES THE FOLLOWING: (B)(6) PATIENT WITH LEFT SUBTROCHANTERIC TRANSVERSE FRACTURE AFTER A FALL. TREATED WITH PFNA NAIL AND BLADE. POSTOPERATIVELY, PATIENT WAS BEDRIDDEN DUE TO PULMONARY COMPLICATIONS. TWO WEEKS POSTOPERATIVELY, PATIENT STARTED PHYSIOTHERAPY WITH NO WEIGHT BEARING AND EXPERIENCED REOCCURRENCE OF PAIN IN LEFT HIP. X-RAY SHOWED BACKOUT OF THE BLADE. AT PATIENT CHECK UP, INFECTION WAS NOTED. THIS IS THE SECOND OF TWO REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFNA BLADE L95 TAN | NONE | KTT | SYNTHES GMBH | 2644460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention | NAIL |