BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN TITANIUM HEXED SCREW

    MDR report key: 11855322 · Received May 20, 2021

    Report

    Report Number
    0001038806-2021-00870
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    May 3, 2021
    Report Date
    September 24, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008545
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CERTAIN® TITANIUM HEXED SCREW (IUNIHT) AND ONE UNK BIOMENT CERTAIN IMPLANT WERE NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES TO ADDRESS REPORTED EVENT. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCTS WERE NOT RETURNED. PRE-EXISTING CONDITION WAS TYPE II (MODERATE) BONE DENSITY. THE DEVICE WAS LOCATED ON TOOTH LOCATION #12 (UNIVERSAL) AND DURATION OF PLACEMENT WAS UNKNOWN DUE TO LIMITED INFORMATION PROVIDED BY CUSTOMER. X-RAY & PICTURE EVALUATION: X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1232107. 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 (1232107) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENTS COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NON-VERIFIABLE AND THE 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 (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED A FRACTURED SCREW IN A WELL SEATED UNK BIOMENT CERTAIN IMPLANT AT SITE # 12. THE SCREW WAS REMOVED AND GOT SUCTIONED DURING PROCEDURE. PATIENT RETURNING FOR SCREW REPLACEMENT. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753003 CERTAIN TITANIUM HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHT 1232107 00844868008545

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention