BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIXMANDIBLE DCP ANGL 3+3HO T1.25 TI

    MDR report key: 3061907 · Received April 16, 2013

    Report

    Report Number
    3003506883-2013-00174
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE 04.503.714 PLATE WAS RECEIVED ALONG WITH SIX SCREWS. THIS EVALUATION IS ONLY ON THE 04.503.714 MATRIXMANDIBLE ANGLE PLATE. AS RECEIVED, THE PLATE HAS BEEN CONTOURED TO FIT THE PATIENT. THIS CONTOURING INTERFERES WITH MEASURING SOME OF THE FEATURES AS THE GAGING AND SPECIFICATIONS ARE MADE TO A PLATE IN THE FLAT CONDITION. THE CONTOURING PROCESS, ALONG WITH IMPLANTATION AND REMOVAL, HAS RESULTED IN MULTIPLE SCRATCHES, NICKS AND DENTS NOTED ON THE TOP AND BOTTOM OF THE PLATE. WHEN HOLDING THE PLATE FACE UP, WITH THE ANGLE FACING AWAY, HOLE NO. 1 TO THE HOLE FARTHEST TO THE LEFT WAS ARBITRARILY ASSIGNED. THE HOLES ARE THEN NUMBERED SEQUENTIALLY ALONG THE PLATE SUCH THAT THE LAST HOLE, FARTHEST TO THE RIGHT, IS HOLE NUMBER 6. THE TOP OF THE PLATE AROUND HOLE NUMBER 6 APPEARS TO HAVE THE HEAVIEST CONCENTRATION OF SCRATCHES. HOLE NUMBER 6 ALSO APPEARS TO BE VISUALLY LARGER THAN THE OTHER HOLES. UNDER MAGNIFICATION, THE THREADS IN HOLE NUMBER 6 HAVE BEEN DAMAGED/STRIPPED OUT, WITH MOST OF THE THREADS ALONG ONE EDGE AND ONE END OF THE HOLE LENGTH COMPLETELY MISSING. DUE TO THE CONTOURING OF THE PLATE AND THE DAMAGE TO HOLE NUMBER 6 NOTED ABOVE, ACCURATE MEASUREMENTS COULD NOT BE MADE USING THE APPROPRIATE GAGES. IT CANNOT BE DETERMINED WHEN, OR HOW THIS DAMAGE WAS DONE TO HOLE NUMBER 6. MEASUREMENTS THAT COULD BE TAKEN WERE FOUND TO MEET SPECIFICATIONS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT IT IS INDEED POSSIBLE, WITH MAXIMAL FORCE THOUGH, TO PUSH THE SCREW HEAD BEYOND THE FIRST PLATE HOLE. UNFORTUNATELY IT IS NOT POSSIBLE TO MEASURE THE PLATE, AS THE DAMAGES ARE TOO GREAT. THE PLATE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. NOTE THAT WE HAVE NOT HAD A SINGLE COMPLAINT WITH THIS PLATE OR THE SCREW SO FAR. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH MANDIBLE PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. POST-OPERATIVELY, IT WAS NOTICED THAT THERE WAS A MALOCCLUSION. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. DURING THE REVISION SURGERY, IT WAS REPORTED THAT A SCREW PULLED THROUGH A HOLE OF THE PLATE. ALL HARDWARE WAS REMOVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162858 MATRIXMANDIBLE DCP ANGL 3+3HO T1.25 TI JEY SYNTHES ELMIRA 6383906

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention