BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLER BENDER FOR RECON MANDIBULAR PLATES

    MDR report key: 2193465 · Received July 13, 2011

    Report

    Report Number
    8010177-2011-00200
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    A RECON PLATE WAS SITTING LOWER ON THE INFERIOR BORDER OF THE MANDIBLE THAN SURGEON WANTED IT. THEREFORE, HE USED THE MANDIBLE ROLLER BENDERS TO BEND THE RECON PLATE WHILE IT WAS FIXATED TO THE PT AS HE DIDN'T WANT TO REMOVE THE ENTIRE PLATE TO MAKE THE BEND. THE DIFFICULT ANGLE CAUSED THE ROLLER BENDERS TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROLLER BENDER FOR RECON MANDIBULAR PLATES INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA AA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK