BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 10222996 · Received July 2, 2020

    Report

    Report Number
    0001038806-2020-00910
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER: (B)(4). ONE CERTAIN GOLD-TITE HEXED SCREW (IUNIHG) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR DUE TO USAGE. THE DEVICE WAS IN GOOD CONDITION. THE CUSTOMER REPORTED REPEATED LOOSENING OF SCREW. THIS INVESTIGATION WAS FOCUSED ONLY ON THE FIRST LOOSENING EVENT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE DEVICE HAD BEEN PLACED ON AN UNKNOWN TOOTH LOCATION FOR AN UNKNOWN AMOUNT OF TIME.X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1193666). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURES. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1193666). ONLY ONE OTHER COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED.JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR; HOWEVER, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT ARE UNKNOWN/VERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. TITLE UNKNOWN/ NOT PROVIDED. FIRST/GIVEN NAME: UNKNOWN / NOT PROVIDED. LAST NAME UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED. OCCUPATION UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED LOOSENING OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688138 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1193666 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1