FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-04499
MDR report key: 3233815
·
Received July 18, 2013
Report
- Report Number
- 2520274-2013-04499
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Report Date
- June 28, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN VA LCP PLATE. 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. PLACEHOLDER.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP DR). POST-OPERATIVELY ON (B)(6)2013, THE PATIENT WAS DIAGNOSED WITH CARPAL TUNNEL SYNDROME. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN VA LCP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334452 | HRS | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |