BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE TM HEXED SCREW

    MDR report key: 6140854 · Received December 2, 2016

    Report

    Report Number
    0001038806-2016-00323
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 10, 2016
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION HAS CONFIRMED THE REPORTED EVENT. THE SCREW WAS FRACTURED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT ABUTMENT SCREW FRACTURED WHEN PATIENT BIT DOWN ON A SANDWICH. THE DENTIST WAS ABLE TO REMOVE THE REMAINS OF THE SCREW FROM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793798 CERTAIN GOLD-TITE TM HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR