FDA Adverse Event
Other
Summary report: N
TROCHANTERIC NAIL KIT, TI ?12X170MM X 125?
MDR report key: 1617142
·
Received February 23, 2010
Report
- Report Number
- 9610622-2010-00082
- Event Type
- Other
- Date Received
- February 23, 2010
- Date of Event
- February 2, 2010
- Report Date
- February 2, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, THE SET SCREW WAS NOT IN THE PACKAGE. AND, THE SURGEON USED SPARE PRODUCT INSTEAD OF IT, SO THE PROCEDURE WAS COMPLETED WITH NO PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI ?12X170MM X 125? | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K205117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |