BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® LARGE HEXED SCREW

    MDR report key: 8191459 · Received December 21, 2018

    Report

    Report Number
    0001038806-2018-01046
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    October 31, 2018
    Report Date
    April 4, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INSPECTION. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. A SINGULAR ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DATE OF THIS REPORT, DATE RECEIVED BY MANUFACTURER, FOLLOW-UP NUMBER, FOLLOW UP TYPE, EVALUATION CODES, ADDITIONAL NARRATIVE/DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510K NUMBER: K072642. DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW (ILRGHG) FRACTURED INSIDE OF THE IMPLANT. TOOTH LOCATION 36.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031147 CERTAIN® GOLD-TITE® LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR