FDA Adverse Event
Injury
Summary report: N
2520274-2013-02832
MDR report key: 3132881
·
Received May 29, 2013
Report
- Report Number
- 2520274-2013-02832
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- April 29, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
A PATIENT UNDERWENT REVISION OF A DISTAL FEMUR PLATE THAT BROKE AT A SCREW HOLE ON AN UNKNOWN DATE. THE FRACTURE WAS NON-UNION AT THE TIME. THE ORIGINAL PLATE WAS IMPLANTED APPROXIMATELY NINE MONTHS EARLIER. A TIBIAL NAIL WAS ALSO REVISED WITH ANOTHER NAIL DUE TO A NON-UNION OF A SEGMENTAL TIBIA. THIS REPORT IS FOR AN UNKNOWN NAIL. THIS IS REPORT 3 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236360 | HSB | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |