FDA Adverse Event
Injury
Summary report: N
UNK - SCREW
MDR report key: 2841010
·
Received November 20, 2012
Report
- Report Number
- 2520274-2012-03290
- Event Type
- Injury
- Date Received
- November 20, 2012
- Report Date
- October 26, 2012
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PART NUMBER AND LOT NUMBER PROVIDED, THEREFORE NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. DEVICE IS NOT BEING RETURNED FOR EVALUATION. WITHOUT THE DEVICE FOR EVALUATION OR PART AND LOT NUMBER, NO FURTHER EVALUATION CAN BE PERFORMED.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED ON (B)(6) 2011. NAIL WAS DYNAMIZED ON (B)(6) 2011. IT IS REPORTED THAT PATIENT FRACTURE IS SLOW TO HEAL DUE TO HEAVY SMOKING. PATIENT PRESENTED TO SURGEON ON UNKNOWN DATE COMPLAINING OF PAIN. X-RAYS TAKEN ON UNKNOWN DATE REVEALED BROKEN NAIL. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. PATIENT WAS TEMPORARILY IMPLANTED WITH ANTIBIOTIC CEMENT NAIL. SURGEON WILL RE-EVALUATE PATIENT ON (B)(6) 2012 FOR POSSIBLE PLATE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK - SCREW | SCREW | HWC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention | NAIL, SCREWS |