FDA Adverse Event
Injury
Summary report: N
2520274-2013-02884
MDR report key: 3132996
·
Received May 29, 2013
Report
- Report Number
- 2520274-2013-02884
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- May 2, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- KWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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
A DISTAL RADIUS PLATE WAS IMPLANTED ON (B)(6) 2012. POST-OPERATIVELY ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE PATIENT REQUIRED A REVISION SURGERY. THE CAUSE OF REVISION WAS LACK OF REDUCTION DUE TO EARLY USE OF THE SURGICAL CORRECTED / NON-UNION WRIST FRACTURE. THE SURGEON REMOVED ALL EXISTING HARDWARE, RE-REDUCED THE FRACTURE AND RE-PLATED WITH SYNTHES PARTS. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235058 | KWP | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |