BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 8056360 · Received November 9, 2018

    Report

    Report Number
    0002023141-2018-00891
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    September 8, 2018
    Report Date
    March 14, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ZIMMER ABUTMENT SCREW WERE RETURNED FOR INSPECTION. THE SCREW SHOWS SIGNS OF DAMAGE AT THE DRIVE FEATURE. THE ABUTMENT IS SIMILARLY DAMAGED, AND IS EXPOSED FROM WHERE THE CROWN WAS CUT. THE COMPLAINT IS NOT VERIFIABLE WITH THE INFORMATION PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO UNAUTHORIZED DEVIATIONS OR NON-CONFORMANCES WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT WERE DOCUMENTED AS PART OF THE DHR. LOT WAS INSPECTED AND ACCEPTED 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: DATE OF THIS REPORT. MANUFACTURER. UDI: (B)(4). DEVICE AVAILABILITY. CONTACT OFFICE - NAME/ADDRESS. DATE RECEIVED BY MANUFACTURER. FOLLOW-UP NUMBER. FOLLOW UP TYPE. DEVICE EVALUATED BY MANUFACTURER: CHANGE "NO" TO "YES". DEVICE MANUFACTURE DATE. EVALUATION CODES. ADDITIONAL NARRATIVE/DATE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS NOT BEEN RETURNED. COVER SCREW SELLS TOGETHER WITH ABUTMENT AS A BUNDLE. ADDITIONAL 510K CODES: K013227, K953101.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABUTMENT SCREW LOOSEN .PATIENT COMPLAINED OF A LOOSE CROWN. CLINICIAN REMOVED CUTTING OFF THE RESTORATION. PATIENT WILL RETURN TO THE OFFICE TO REDO THE ABUTMENT CROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895243 ABUT GOLD FRICTION-FIT 3. 5MM IMP ABUTMENT DZE ZIMMER DENTAL 2018032113

    Patients

    Seq Age Sex Outcome Treatment
    1