BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 12787114 · Received November 10, 2021

    Report

    Report Number
    0002023141-2021-03172
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    October 11, 2021
    Report Date
    April 26, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿ K101880. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSFER MOUNT FRACTURED IN THE IMPLANT WHEN DELIVERING THE IMPLANT TO TOOTH SITE #19. THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW ONE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688777 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB10 1242434 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male