BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    MDR report key: 8927476 · Received August 23, 2019

    Report

    Report Number
    0002023141-2019-00645
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    April 16, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW-VENT IMPLANT WITH MP-1 HA DUAL TRANSITION SELECTIVE SURFACE (TSVH11) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE HEX AND EXTERNAL AND INTERNAL THREADS OF THE AS RETURNED PRODUCT WERE DAMAGED. THE ASSOCIATED MOUNT WAS NOT RETURNED WITH THE IMPLANT. FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED SINCE THE PRODUCT WAS DAMAGED. 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. A ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED AS THE EVENT CANNOT BE RECREATED. COMPLAINT IS THEREFORE NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: UDI: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510K NUMBER: K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOUNT WOULD NOT DISENGAGE FROM THE BUNDLED IMPLANT (TSVH11) DURING PLACEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718717 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 63816782

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR