FDA Adverse Event
Malfunction
Summary report: N
CANNULATED SCREW ASNIS III Ø6.5X105MM TL20MM
MDR report key: 3181257
·
Received June 21, 2013
Report
- Report Number
- 0008031020-2013-00202
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- June 6, 2013
- Report Date
- June 6, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-SELZACH
- Product Code
- HWC
- PMA / PMN Number
- K000080
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT HAD 3 CANULATED SCREWS AND FEMORAL HEAD. THE FEMORAL HEAD FRACTURED, SO THE SURGEON REVISED TO A TOTAL HIP. REMOVED THE SCREWS ONLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282832 | CANNULATED SCREW ASNIS III Ø6.5X105MM TL20MM | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS-SELZACH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |