BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEIN DENTAL ELEVATOR, 2MM, STRAIGHT

    MDR report key: 1701333 · Received May 19, 2010

    Report

    Report Number
    8010177-2010-00216
    Event Type
    Malfunction
    Date Received
    May 19, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 26, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    EMJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULT SHOWS THAT THE DEVICE WAS DEFORMED DUE TO A HIGH BENDING FORCES RESULTING FROM INAPPROPRIATE USER HANDLING. INDICATIONS FOR MATERIAL OR MFG RELATED PROBLEMS WERE NOT FOUND DURING INVESTIGATION. BASED ON THE STATISTICAL EVAL, NO INDICATION WAS FOUND FOR ANY DEVICE RELATED ISSUE.

    Description of Event or Problem · 1

    THE TIP CAME OFF DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEIN DENTAL ELEVATOR, 2MM, STRAIGHT INSTRUMENT EMJ STRYKER OSTEOSYNTHESIS FREIBURG NA JAD00F6000/Y9

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK