BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.7MM MTX FULL, 10

    MDR report key: 15105865 · Received July 26, 2022

    Report

    Report Number
    0002023141-2022-01872
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Report Date
    December 27, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019034
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510: KK113753, 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 (1240717). 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 (1240717) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED.OCT 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.THE FOLLOWING SECTIONS HAVE BEEN UPDATED:B4: DATE OF THIS REPORT.G3: DATE RECEIVED BY MANUFACTURER.G6: CHECKED "FOLLOW-UP".H2: CHECKED FOLLOW-UP TYPE.H3: CHANGED "YES" TO "NO".H6: ENTERED EVALUATION CODES.H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS MISSING FROM THE PACKAGING. THE DOCTOR WAS IN SURGERY AND OPENED THE PACKAGING THAT WAS SEALED AND THE TUBE INSIDE THAT HAS THE IMPLANT IN IT WAS EMPTY. CUSTOMER CONFIRMED THAT THEY COMPLETED THE PROCEDURE WITH ANOTHER IMPLANT.

    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
    632895 IMP TM 4.7MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMMER DENTAL TMTWB10 1240717 00889024019034

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose