FDA Adverse Event
Injury
Summary report: N
3.5 MM LOCKING SCREW
MDR report key: 1202803
·
Received October 17, 2008
Report
- Report Number
- 2520274-2008-00087
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- May 23, 2008
- Report Date
- September 24, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURER, THE 510K NUMBER, OR THE DEVICE MANUFACTURE DATE WITHOUT A LOT AND PART NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
SURGEON WAS IMPLANTING A 3.5 MM LCP MEDIAL DISTAL TIBIA PLATE AND A 3.5 MM LOCKING SCREW WENT THROUGH A HOLE IN THE PLATE. PT REVISED DUE TO PLATE BREAKAGE; NON UNION WAS NOTED. SCREW WAS EXPLANTED AT THE TIME OF THIS REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5 MM LOCKING SCREW | NI | HWC | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PLATE |