FDA Adverse Event
Injury
Summary report: N
COMPRESSION PLATE T-SHAPED
MDR report key: 3250005
·
Received July 24, 2013
Report
- Report Number
- 9615741-2013-00031
- Event Type
- Injury
- Date Received
- July 24, 2013
- Report Date
- July 24, 2013
- Manufacturer
- NEWDEAL SAS
- Product Code
- HRS
- PMA / PMN Number
- K093914
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
IT WAS REPORTED UNICP PLATE BROKE AFTER IMPLANTATION. ADD'L INFO WAS REQUESTED BY INTEGRA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 345424 | COMPRESSION PLATE T-SHAPED | HRS | NEWDEAL SAS | EMTQ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |