BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD-TITE® SQUARE UNISCREW

    MDR report key: 12460475 · Received September 13, 2021

    Report

    Report Number
    0001038806-2021-01749
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 20, 2021
    Report Date
    February 8, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868017325
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE GOLD-TITE® SQUARE UNISCREW (UNISG) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED PRODUCT IDENTIFIED SOME SIGNS OF USE BUT NO APPARENT MALFUNCTION. HOWEVER, ONE UNKNOWN IMPLANT WAS NOT RETURNED. AS PER INFORMATION PROVIDED BY CUSTOMER, THIS SCREW WAS RETIGHTENED AFTER THIS REPORTED EVENT OCCURRED. FUNCTIONAL TESTING FOR RETURNED PRODUCT WAS PERFORMED AND NO MALFUNCTION IDENTIFIED WHEN USED WITH IN-HOUSE DEVICE. PRE-EXISTING CONDITIONS AS NOTED ON THE PER WAS UNKNOWN. THE DEVICES WERE LOCATED ON TOOTH SITE #17 (UNIVERSAL) AND PLACED SINCE (B)(6)2021, NOT REMOVED YET. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1242097. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1242097) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. COMPLAINT HISTORY AND DHR REVIEW FOR UNKNOWN IMPLANT COULD NOT BE PERFORMED AS THE ITEM NUMBER AND LOT NUMBER WAS NOT AVAILABLE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION FOR UNISG SCREW HAS NOT OCCURRED AND FOR UNKNOWN IMPLANT COULD NOT BE VERIFIED AND THE REPORTED EVENTS COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NON-VERIFIABLE AND ALL REPORTED PRODUCTS WERE NOT RETURNED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW LOOSENED IN THE PATIENTS MOUTH. IT WAS RETIGHTENED AND WILL BE REPLACED ONCE THEY RECEIVE REPLACEMENT. TOOTH #17.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355556 GOLD-TITE® SQUARE UNISCREW DENTAL SCREW NHA BIOMET 3I UNISG 1242097 00844868017325

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male