BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE Y-PLATE, 7HOLE, MIDFACE

    MDR report key: 1811320 · Received August 19, 2010

    Report

    Report Number
    8010177-2010-00287
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 13, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES NOT AVAILABLE FOR RETURN. INTERNAL INVESTIGATION IN PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GENIOPLASTY SURGERY, THE DOCTOR ATTEMPTED TO BEND PLATE (B)(4) USING AN UPPER MID-FACE 90 DEGREE BENDER. IT WAS REPORTED THAT THE PLATE BROKE IN HIS HAND. ADDITIONALLY IT WAS REPORTED THAT THE BROKEN PLATE WAS DISCARDED AND TWO NEW PLATES WERE SUCCESSFULLY BENT AND IMPLANTED. UPON NEXT-DAY FOLLOW UP IT WAS REPORTED THAT THE PATIENT'S JAW HAD SHIFTED, REQUIRING EMERGENCY REVISION SURGERY. IT WAS REPORTED THAT DURING THE REVISION THE DOCTOR DISCOVERED THAT ONE OF THE PLATES HAD SNAPPED AT ONE BEND AND THAT THE OTHER PLATE HAD SNAPPED AT BOTH BENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE Y-PLATE, 7HOLE, MIDFACE IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK