BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOHORIZONS PHA

    MDR report key: 1353719 · Received March 11, 2009

    Report

    Report Number
    1060818-2009-00001
    Event Type
    Other
    Date Received
    March 11, 2009
    Date of Event
    February 10, 2009
    Report Date
    March 10, 2009
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORD REVIEW DEMONSTRATED DEVICE MET DESIGN REQUIREMENTS.

    Description of Event or Problem · 1

    THE O-RING GOT STUCK AND THEY COULD NOT REMOVE THE PHA DRIVER INSTRUMENT FROM THE IMPLANT. IMPLANT HAD TO BE REMOVED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOHORIZONS PHA INTERNAL HANDPIECE ADAPTER DZE BIOHORIZONS IMPLANT SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other