BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 3505977 · Received December 9, 2013

    Report

    Report Number
    2520274-2013-07623
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Date of Event
    November 11, 2013
    Report Date
    November 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CODE: DZL. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A PROCEDURE THE SURGEON WAS PLACING A MATRIXMIDFACE 6MM SCREW TO FIXATE A SYNPOR REINFORCED FAN PLATE TO THE ORBITAL RIM AND THE HEAD OF THE SCREW SNAPPED OFF. THE HOLE WAS NOT PRE-DRILLED. THE HEAD OF THE SCREW WAS RECOVERED AND REMOVED FROM THE PATIENT. THE SHAFT OF THE SCREW REMAINS IN THE PATIENT. THE SURGEON THEN PRE-DRILLED AND PLACED A NEW MATRIXMIDFAC SCREW IN THE NEXT HOLE OF THE PLATE WITHOUT ISSUE. THE FRACTURES WERE REPAIRED AND THE PROCEDURE WAS COMPLETED. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639094 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR