BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 7367146 · Received March 23, 2018

    Report

    Report Number
    0001038806-2018-00303
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    March 1, 2017
    Report Date
    July 25, 2018
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT # (B)(4). ONE CERTAIN® TITANIUM LARGE HEXED SCREW WAS RETURNED FOR INSPECTION. THE SCREW WAS FRACTURED AT THE TOP OF THE THREADED REGION. THE DRIVE FEA TURE IS WORN BUT FUNCTIONAL. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: BIOMET 3I RESTORATIVE MANUAL INSTRM REV C 09/16. INFORMATION IDENTIFIED: THE BIOMET 3I RESTORATIVE MANUAL WAS CONFIRMED TO CONTAIN INSTRUCTION ON SCREW PLACEMENT AS WELL AS RECOMMENDED TORQUE VALUES. IN THE CASE OF CERTAIN® TITANIUM LARGE HEXED SCREWS, IT IS RECOMMENDED TO TORQUE AT 20NCM. COMPLAINT INDICATES SCREW FRACTURE. ALLEGED EVENT WAS CONFIRMED FOLLOWING INSPECTION. A SINGULAR ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510K NUMBER: K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW (ILRGHT) FRACTURED. THE IMPLANT IS OK. TOOTH LOCATION 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210005 CERTAIN® TITANIUM LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1