FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
MDR report key: 3200833
·
Received July 2, 2013
Report
- Report Number
- 0009610622-2013-00368
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 8, 2013
- Report Date
- June 13, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING A SURGERY, THE SURGEON DECIDES TO IMPLANT THE PATIENT TWO EXPIRED REFERENCES. BOTH EXPIRED REFERENCES WERE STERILIZATED BEFORE IMPLANTATION BY IMMERSION IN HYDROGEN PEROXIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303185 | LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS-KIEL | K543451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |