FDA Adverse Event
Malfunction
Summary report: N
SURFIX STE. - S-STEEL - DIA3.5 L24MM - STERILE
MDR report key: 2550804
·
Received April 23, 2012
Report
- Report Number
- 9615741-2012-00024
- Event Type
- Malfunction
- Date Received
- April 23, 2012
- Date of Event
- March 27, 2012
- Report Date
- April 23, 2012
- Manufacturer
- NEWDEAL SAS
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS 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 IT WAS SEEN ON X-RAY THAT THE INTERFRAGMENTARY SCREW HAD BROKEN SOME TIME AFTER IMPLANTATION. THE X-RAY SHOWED THAT OTHER SCREWS THAT HAD BEEN INSERTED WITH THE TIBIAXYS ANTERIOR PLATING SYSTEM 150010 LOT NUMBER EC99, AND 150020 LOT NUMBER EDV6 HAD BROKEN OR BACKED OUT A LITTLE. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURFIX STE. - S-STEEL - DIA3.5 L24MM - STERILE | N/A | HWC | NEWDEAL SAS | EPSL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |