FDA Adverse Event
Other
Summary report: N
UNI-CP COMPRESSION PLATE
MDR report key: 1246430
·
Received November 25, 2008
Report
- Report Number
- 9615741-2008-00033
- Event Type
- Other
- Date Received
- November 25, 2008
- Date of Event
- September 15, 2008
- Report Date
- November 25, 2008
- Manufacturer
- NEWDEAL S.A.
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
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 UPON THE REPORTED INFO.
Description of Event or Problem · 1
UNITHE SURGERY FOR TALONAVICULAR FUSION TOOK PLACE IN SEPTEMBER. WHEN THE PT HAD AN X-RAY AT A FOLLOW UP EXAMINATION, IT SHOWED THAT THE COMPRESSION PLATE HAD BROKEN. THE DOCTOR WILL REMOVE THE BROKEN PLATE. INTEGRA REQUESTED THAT THE BROKEN PLATE BE SAVED FOR EVAL. FURTHER CLINICAL INFO HAS BEEN REQUESTED IN WRITING FROM THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNI-CP COMPRESSION PLATE | LOWER EXTREMITY COMPRESSION PLATE | HRS | NEWDEAL S.A. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |