FDA Adverse Event
Injury
Summary report: N
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X37,5 MM
MDR report key: 3346440
·
Received September 13, 2013
Report
- Report Number
- 0009610622-2013-00504
- Event Type
- Injury
- Date Received
- September 13, 2013
- Date of Event
- August 15, 2013
- Report Date
- August 15, 2013
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- HSB
- PMA / PMN Number
- K003018
- Adverse Event
- Yes
- Product Problem
- 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.
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE PRODUCT AND ESPECIALLY THE PACKAGING WERE NOT AVAILABLE FOR INVESTIGATION. A REVIEW OF THE DHR REVEALED NO NON-CONFORMITIES. MEDICAL DATA WAS REQUESTED BY DQF 13-003 (CUSTOMER CHECKLIST) BUT FINALLY NOT PROVIDED. CLINICAL ASSESSMENT BY A MEDICAL EXPERT COULD NOT BE OBTAINED.
Description of Event or Problem · 1
DUE TO INFECTION THE GAMMA NAIL AND LAG SCREW WERE REMOVED. THE SURGEON THEN WASHED OUT AREA AND IMPLANTED NEW DEVICES.
Description of Event or Problem · 1
DUE TO INFECTION THE GAMMA NAIL AND LAG SCREW WERE REMOVED. THE SURGEON THEN WASHED OUT AREA AND IMPLANTED NEW DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460607 | LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X37,5 MM | IMPLANT | HSB | STRYKER TRAUMA KIEL | K567690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |