FDA Adverse Event
Injury
Summary report: N
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 58MM FOR IM NAILS
MDR report key: 3151333
·
Received June 7, 2013
Report
- Report Number
- 2520274-2013-02900
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- May 16, 2013
- Report Date
- May 20, 2013
- Manufacturer
- SYNTHES
- Product Code
- HWC
- PMA / PMN Number
- K000089
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
FEMORAL SHAFT NON UNION. EXCHANGED NAIL TO LARGER DIAMETER. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253337 | 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 58MM FOR IM NAILS | HWC | SYNTHES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |