BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE

    MDR report key: 8511315 · Received April 12, 2019

    Report

    Report Number
    0002023141-2019-00155
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    February 19, 2019
    Report Date
    June 13, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    AN ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE (HLA4/5) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SOME SIGNS OF WEAR FROM USE, BUT NO SIGNS OF SIGNIFICANT DAMAGE OR DEFORMATION WERE NOTED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. A SINGULAR ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: UDI: (B)(4). DEVICE EVALUATED BY MANUFACTURER: CHANGE "NO" TO "YES."

    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). DEVICE ADDITIONAL 510(K): K013227 AND K953101.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (HLA4/5) WAS LOOSENED. IT WAS ALSO REPORTED THAT THE IMPLANT WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301025 ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE ABUTMENT SCREW DZE ZIMMER DENTAL 2018050237

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR