BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    MDR report key: 9597888 · Received January 16, 2020

    Report

    Report Number
    0002023141-2020-00109
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 17, 2019
    Report Date
    March 30, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. WITHOUT THE RETURNED PRODUCT, THERE IS NOT ENOUGH EVIDENCE TO FORM A CONCLUSION ON THE REPORTED EVENT. THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT ID AND WEIGHT NOT PROVIDED/UNKNOWN. REPORTER'S FIRST NAME NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K101880. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEX TOOL AND IMPLANT COULD NOT DISENGAGE. AS A RESULT, THE IMPLANT HAD TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT AND TOOL. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62031 IMP,TSV,MCOL MG,4.7MM,11.5MML DENTAL IMPANT DZE ZIMMER DENTAL 1228055

    Patients

    Seq Age Sex Outcome Treatment
    1