FDA Adverse Event
Injury
Summary report: N
4.5MM VA-LCP CURVED CONDYLAR PLATE /12 HOLE/266MM/LEFT
MDR report key: 4222861
·
Received November 4, 2014
Report
- Report Number
- 2520274-2014-14470
- Event Type
- Injury
- Date Received
- November 4, 2014
- Report Date
- October 8, 2014
- Manufacturer
- SYNTHES USA
- Product Code
- JDP
- PMA / PMN Number
- PK110354
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PREVIOUSLY IMPLANTED CURVED CONDYLAR PLATE WAS FOUND TO HAVE BROKEN DOWN THE MIDDLE AND A NON-UNION WAS PRESENT. A REVISION WAS PERFORMED SUCCESSFULLY WITH NO REPORTED SURGICAL DELAY OR PATIENT HARM. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707575 | 4.5MM VA-LCP CURVED CONDYLAR PLATE /12 HOLE/266MM/LEFT | IMPLANT, FIXATION, DEVICE | JDP | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |