BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,3.7MM,11.5MML

    MDR report key: 16397900 · Received February 17, 2023

    Report

    Report Number
    0002023141-2023-00582
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    February 17, 2022
    Report Date
    May 30, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019737
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN PICKING UP THE IMPLANT FROM THE BLISTER, MOUNT DISENGAGED AND IMPLANT FELT DOWN TO THE FLOOR. SURGICAL PROCEDURE WAS COMPLETED BY INSERTING ANOTHER IMPLANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110378 IMP,TSV,MCOL MG,3.7MM,11.5MML DENTAL IMPLANT DZE ZIMMER DENTAL TSVMB11 1243032 00889024019737

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female