BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM RECONSTRUCTION, 14 HOLE STRAIGHT LOCKING

    MDR report key: 3820730 · Received May 1, 2014

    Report

    Report Number
    2027754-2014-00006
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 28, 2014
    Manufacturer
    OSTEOMED
    Product Code
    JEY
    PMA / PMN Number
    K080694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT WAS PIECED TOGETHER TO SHOW THE 34 DEGREES BEND OF THE STRAIGHT PLATE. DOCTOR HAS CONTROL OVER CONTOURING PLATE TO DESIRED SHAPE HOWEVER THE 34 DEGREES ANGLE MAY HAVE CAUSED A WEAK SPOT IN THE BEND AREA. IT MAY HAVE BEEN BETTER TO BEND OVER A THREE HOLE SPAN RATHER THAN A SINGLE HOLE SPAN. IT IS LIKELY THAT THE PLATE MAY HAVE HAD A SMALL CRACK FORM WHEN IT WAS CONTOURED TO FIT PATIENT ANATOMY. THIS CRACK WOULD HAVE PROPAGATED WITH THE CYCLIC LOADING THAT IT SAW AS THE PATIENT STARTED EATING AGAIN DURING RECOVERY. WHY DOCTOR WAITED OVER TWO MONTHS TO EXPLANT IS UNKNOWN. GENERAL SURGICAL TECHNIQUE GUIDES POINT TO VARIOUS TECHNIQUE TIPS AND NOTES TO ASSIST IN OBTAINING THE BEST BENDS.

    Description of Event or Problem · 1

    PATIENT WAS TREATED FOR A FRACTURE AT THE ANGLE OF THE MANDIBLE WITH OSTEOMED PART NUMBER 214-2417. SOMETIME BETWEEN THE INITIAL SURGERY WHICH TOOK PLACE ON (B)(6) 2013 AND (B)(6)2014 THE RECONSTRUCTION PLATE THAT WAS PLACED BROKE. (B)(6) WAS WHEN THE DOCTOR NOTICED THE FRACTURE. EXPLANT OF THE BROKEN PLATE TOOK PLACE ON (B)(6) 2014. THE CURRENT STATUS OF THE PATIENT IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262416 2.4MM RECONSTRUCTION, 14 HOLE STRAIGHT LOCKING 2.4 MM RECONSTRUCTION PLATE JEY OSTEOMED

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention