BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 8338875 · Received February 14, 2019

    Report

    Report Number
    0001038806-2019-00111
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 14, 2019
    Report Date
    June 18, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CERTAIN® TITANIUM LARGE HEXED SCREW (ILRGHT) WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED THAT THE SCREW WAS FRACTURED AT THE THREADS. THE ALLEGED DEVICE MALFUNCTION WAS CONFIRMED. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. A ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED. UDI: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT'S AGE NOT PROVIDED/UNKNOWN. PATIENT'S WEIGHT NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW (ILRGHT) FRACTURED INSIDE OF THE IMPLANT. THE FRACTURED PIECE COULD NOT BE REMOVED. AS A RESULT, THE IMPLANT WAS REMOVED. TOOTH LOCATION 16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132668 CERTAIN® TITANIUM LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I 1216147

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention XIFNT411| XIFNT411