FDA Adverse Event
Injury
Summary report: N
2520274-2013-02863
MDR report key: 3132902
·
Received May 29, 2013
Report
- Report Number
- 2520274-2013-02863
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- May 1, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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
DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2013, A PATIENT UNDERWENT SURGERY FOR A TALO-NAVICULAR FUSION, WITH CHARCOT SYMPTOMS. THE VARIABLE ANGLE FOOT SET WAS USED. POST-OPERATIVE X-RAYS ON AN UNKNOWN DATE SHOWED THE OPERATION HAD FAILED. THE VARIABLE ANGLE LOCKING SCREWS HAD PULLED OUT OF THE PLATE. A REVISION SURGERY WILL BE NECESSARY. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235300 | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |