FDA Adverse Event
Malfunction
Summary report: N
PANTA IMPLANT SET
MDR report key: 1950309
·
Received December 14, 2010
Report
- Report Number
- 9615741-2010-00066
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- November 26, 2010
- Report Date
- December 14, 2010
- Manufacturer
- NEWDEAL S.A.S.
- Product Code
- JDS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT DURING A SURGICAL PROCEDURE TO INSERT A PANTA NAIL FOR TIBIO-TALO-CALCANEAL ARTHRODESIS, THE TIBIAL SCREWS THAT WERE INSERTED THROUGH THE PANTA JIG WERE NOT ALIGNED CORRECTLY WITH THE HOLES IN THE PANTA INTERMEDULLARY NAIL. THE SURGEON THEN PLACED THE SCREWS CORRECTLY UNDER X-RAY GUIDANCE. INTEGRA HAS REQUESTED ADD'L CLINICAL INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PANTA IMPLANT SET | NA | JDS | NEWDEAL S.A.S. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NOT APPLICABLE. |