FDA Adverse Event
Malfunction
Summary report: N
COMPRESSION PLATE 2 HOLE 20MM
MDR report key: 2479448
·
Received February 23, 2012
Report
- Report Number
- 9615741-2012-00009
- Event Type
- Malfunction
- Date Received
- February 23, 2012
- Date of Event
- February 9, 2012
- Report Date
- February 23, 2012
- Manufacturer
- NEWDEAL S.A.
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT HE HAS HAD TWO PTS WHOSE UNI-CP COMPRESSION PLATE HAS BROKEN POST SURGERY. TWO PRECISE CATALOGUE NUMBER OF THE PLATE IS NOT KNOWN. INTEGRA HAS REQUESTED ADD'L INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPRESSION PLATE 2 HOLE 20MM | UNI-CP | HRS | NEWDEAL S.A. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |