BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® LARGE HEXED SCREW

    MDR report key: 7882359 · Received September 17, 2018

    Report

    Report Number
    0001038806-2018-00817
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CERTAIN GOLD-TITE LARGE HEXED SCREW WAS RETURNED FOR INSPECTION . THE COLLAR, DRIVE FEATURE, AND BODY WAS NOTED TO BE WORN, INDICATING USE. THE THREADS ARE SIMILARLY WORN AND CONTAIN SOME DEBRIS. 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 GOLD-TITE LARGE HEXED SCREWS, IT IS RECOMMENDED TO TORQUE AT 20NCM. THE REPORTED EVENT CANNOT BE RECREATED AND THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. BASED ON THE VISUAL INSPECTION AND COMPARISON TO PRODUCT DRAWING 223090 REV K, NO DEVICE MALFUNCTION WAS FOUND.

    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 CODES: K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED FOR A CLEANING AND LOOSE SCREW WAS DISCOVERED. DENTAL IMPLANT DID NOT HAVE ANY DAMAGE. SCREWS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722458 CERTAIN® GOLD-TITE® LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1