BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.7MM MTX FULL, 10

    MDR report key: 15210112 · Received August 11, 2022

    Report

    Report Number
    0002023141-2022-02028
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    July 28, 2022
    Report Date
    January 9, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019034
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. GENDER UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED. K113753, K112160.

    Additional Manufacturer Narrative · 0

    AN IMP TM 4.7MM MTX FULL, 10 (TMTWB10) WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. VIAL WAS RETURNED AND SEAL HAS BEEN BROKEN AND OPENED. NO PRODUCTS INSIDE. PICTURES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1240272). 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 (1240272) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. NOV POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO OPEN AN IMPLANT PACKAGE FOR A CASE AND THE VIAL WAS EMPTY. WAS DISCOVERED WHEN THE ASSISTANT WENT TO OPEN THE IMPLANT FOR PLACEMENT. WHEN THEY OPENED THE VIAL, THERE WAS NO IMPLANT INSIDE. WE DID HAVE OTHER IMPLANTS IN STOCK SO WE WERE ABLE TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163679 IMP TM 4.7MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMMER DENTAL TMTWB10 1240272 00889024019034

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose