BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE LARGE HEXED SCREW

    MDR report key: 10367582 · Received August 5, 2020

    Report

    Report Number
    0001038806-2020-01075
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    February 20, 2020
    Report Date
    November 30, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868006121
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ALTHOUGH THE MANUFACTURER (ZB EU AUTHORIZED REPRESENTATIVE) HAS RECEIVED THE PRODUCT (ILRGHG) THE MANUFACTURING/INVESTIGATION SITE HAS NOT RECEIVED/EVALUATED THE ACTUAL DEVICES DUE TO COVID PROTOCOLS AND DELAYS IN SHIPMENT (LOST IN TRANSIT BY UPS, TRACKING (B)(4). THEREFORE, THE PRODUCTS HAS NOT BEEN PHYSICALLY INSPECTED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS THE PRODUCT HAS NOT BEEN PHYSICALLY INSPECTED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE EVENT OCCURRED AT TOOTH SITE 14 (FDI). THE IMPLANT HAD BEEN PLACED FOR APPROXIMATELY 1 YEAR. X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. DHR REVIEW FOR THE LOT (1192745 ) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PRODUCT WAS CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE LOT (1192745) FOR SIMILAR EVENT AND NO OTHER COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED DEVICES AND EVENTS.THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE PRODUCT HAS NOT BEEN PHYSICALLY INSPECTED.

    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). WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835433 CERTAIN GOLD-TITE LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I ILRGHG 1192745 00844868006121

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR