FDA Adverse Event
Injury
Summary report: N
2520274-2013-01073
MDR report key: 2970788
·
Received February 20, 2013
Report
- Report Number
- 2520274-2013-01073
- Event Type
- Injury
- Date Received
- February 20, 2013
- Report Date
- December 14, 2012
- 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 BE 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) 2012 PATIENT WAS IMPLANTED WITH UNKNOWN SYNTHES HARDWARE. IT IS REPORTED THAT POST-OPERATIVELY, PATIENT HAD SEVERE PERSISTING PAIN. IT IS REPORTED THAT IT MAY NOT BE RELATED TO IMPLANTED HARDWARE, BUT THE POSSIBLE RELATIONSHIP COULD NOT BE EXCLUDED. HARDWARE HAS NOT BEEN EXPLANTED. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74294 | HWC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |