BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 8277216 · Received January 25, 2019

    Report

    Report Number
    0001038806-2019-00064
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    October 5, 2018
    Report Date
    May 13, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CERTAIN® TITANIUM LARGE HEXED SCREW (ILRGHT) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURE CONFIRMED ON THREADED PORTION OF SCREW. THE HEX HEAD IS WORN AND CONTAINS DEBRIS. THEREFORE, BASED ON THE EVALUATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING INSPECTION. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510K NUMBER: K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW (ILRGHT) FRACTURED. THE FRACTURED PORTION OF THE SCREW WAS ABLE TO BE REMOVED FROM THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71942 CERTAIN® TITANIUM LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1