BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 7850946 · Received September 6, 2018

    Report

    Report Number
    0002023141-2018-00785
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    July 31, 2018
    Report Date
    January 17, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR EVALUATION. HOWEVER, THE PRODUCT WAS MISPLACED IN HOUSE PRIOR TO AN EVALUATION BEING PERFORMED. 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 PRODUCT MANUAL AND INSTRUCTIONS FOR USE WERE REVIEWED. BASED ON THE DHR REVIEW, THE MALFUNCTION COULD NOT BE CONFIRMED. A ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED. UDI: (B)(4). DEVICE EVALUATED BY MFR: CHANGED "NO" TO "YES".

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) NUMBER K101880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSFER MOUNT ((B)(4)) FRACTURED INSIDE THE IMPLANT. IT WAS ALSO REPORTED THAT THEY REMOVED AND REPLACED ANOTHER IMPLANT WITHIN THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692713 IMP,TSV,4.7,10,MTX,MG IMPLANT DZE ZIMMER DENTAL 63265908

    Patients

    Seq Age Sex Outcome Treatment
    1