FDA Adverse Event
Other
Summary report: N
TROCHANTERIC NAIL KIT, TI 11X180 MM X 120
MDR report key: 1631243
·
Received March 9, 2010
Report
- Report Number
- 9610622-2010-00106
- Event Type
- Other
- Date Received
- March 9, 2010
- Date of Event
- January 28, 2010
- Report Date
- February 19, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICES WILL NOT BE RETURNED. NO EVAL WILL BE PERFORMED. IF THE DEVICE OR ADD'L INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, THE SURGEON REMOVED A GAMMA NAIL TO CONVERT PT TO A TOTAL HIP. THEY MADE ME AWARE OF THIS AT THE TIME OF THIS REPORT AND DID NOT HAVE IMPLANT #5 AVAILABLE AS THEY WERE SENT TO THEIR LAB FOR PROCESSING. THERE WERE NO ADVERSE EVENTS DURING THE REMOVAL, AND IT WAS REMOVED FOR CONVERSION PURPOSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI 11X180 MM X 120 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |