BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.85MM TI MATRIX SCREW/COARSE

    MDR report key: 2094012 · Received April 20, 2011

    Report

    Report Number
    8030965-2011-00203
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE. DEVICE WAS NOT EXPLANTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING INSERTION, IT WAS NOTED THAT THREE CORTICAL SCREWS WERE POSITIONED INCORRECTLY. SURGEON TRIED TO REMOVE SCREWS AND SCREWS WOULD NOT BACK OUT. SURGEON STATED, THE SCREWDRIVER BLADE WAS SEATED IN THE SCREW HEAD RECESS BUT AS SCREW WAS BEING BACKED OUT, IT WOULD SLIP OUT AND THE SCREW WOULDN'T MOVE. AFTER NUMEROUS ATTEMPTS, SURGEON SUCCESSFULLY REMOVED ONE OF THE SCREWS WHILE THE OTHER TWO REMAIN IN THE PATIENT. THE SURGEON COMMENTED THAT THE COMPLAINT EVENT DID NOT COMPROMISE THE PATIENT. THIS IS THE 1ST OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.85MM TI MATRIX SCREW/COARSE MATRIX SCREW/COARSE JEY SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SCREWS