FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-02487
MDR report key: 3102934
·
Received May 9, 2013
Report
- Report Number
- 2520274-2013-02487
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Report Date
- April 16, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- GXN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, SURGEON EXPRESSED DISSATISFACTION WITH THE MATRIX NEURO PLATING SYSTEM. THE LOW-PROFILE PLATES ARE NOT HOLDING THE BONE IN PLACE. DURING PATIENT FOLLOW-UP, IT IS OBSERVED THAT PLATES ARE SINKING OR SUBSIDENCE OF THE FLAPS IS OCCURRING. IT WAS ALSO NOTED THAT MORE PLATES AND SCREWS WERE BEING USED COMPARED TO OTHER SYSTEMS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204509 | GXN | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |