BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRA INTERNAL ABUTMENT - LEVEL DRIVER, RATCHET

    MDR report key: 1246352 · Received November 19, 2008

    Report

    Report Number
    1060818-2008-00001
    Event Type
    Other
    Date Received
    November 19, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 19, 2008
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Product Code
    DZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRA WAS OVERLOADED CAUSING YIELDING AND FRACTURE OF THE TIP.

    Description of Event or Problem · 1

    PRA BROKE WHILE DRIVING THE IMPLANT INTO THE OSTEOTOMY. IMPLANT WAS REMOVED BECAUSE A FRAGMENT OF THE DRIVER COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRA INTERNAL ABUTMENT - LEVEL DRIVER, RATCHET PRA INTER. ABUTMENT - LEVEL DRIVER, RATCHET DZJ BIOHORIZONS IMPLANT SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention