FDA Adverse Event
Injury
Summary report: N
STANDARD BARREL HIP PLATE, KEYLESS OMEGA 3 135°, 4 HOLES
MDR report key: 3200798
·
Received July 2, 2013
Report
- Report Number
- 0008031020-2013-00214
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- April 11, 2013
- Report Date
- April 11, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-SELZACH
- Product Code
- KTT
- PMA / PMN Number
- K062066
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS INITIALLY DONE (B)(6) 2013, BROUGHT PATIENT BACK IN (B)(6) 2013 AND PUT IN AN OMEGA. PATIENT HAD BONE LOSS AND FRACTURE AND COULDN'T GET FIXATION. SURGEON PUT IN A RESTORATION MODULAR WITH DALL MILES CABLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303310 | STANDARD BARREL HIP PLATE, KEYLESS OMEGA 3 135°, 4 HOLES | IMPLANT | KTT | STRYKER OSTEOSYNTHESIS-SELZACH | X03838 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |