BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 4. 5MM IMP

    MDR report key: 7033647 · Received November 15, 2017

    Report

    Report Number
    0001038806-2017-00811
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 24, 2017
    Report Date
    February 5, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABUTMENT SCREW WAS RETURNED WITH A FRACTURED HEX FROM A FRICTION FIT GOLD ABUTMENT (HLA4G). VISUAL INSPECTION OF THE AS RECEIVED PRODUCT IDENTIFIED SIGNIFICANT WEAR AROUND THE THREADS, SHANK, AND THE COLLAR. THERE WAS NOTICEABLE GOUGING AROUND THE HEX CIRCUMFERENCE AND THE HEX FEATURE APPEARED TO BE STRIPPED. THE ABUTMENT HEX HAD FRACTURED HORIZONTALLY ACROSS THE BASE OF THE SEATING SURFACE. THE ABUTMENT POST WAS NOT RETURNED FOR INSPECTION. NO ADDITIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE RETURNED PRODUCTS. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED. THE COMPLAINT COULD NOT BE VERIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: THE COMPLAINT COULD NOT BE VERIFIED, AS THE EXACT DETAILS OF THE DEVICE USAGE WERE UNKNOWN AND THE REPORTED LOOSENING COULD NOT BE REPLICATED. THE SCREW HAD EXCESSIVE WEAR DUE TO USAGE AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THEREFORE, BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. DATE OF THIS REPORT, DATE RECEIVED BY MANUFACTURER, ADDED FOLLOW UP TYPE, DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO¿ TO ¿YES¿, ADDED EVALUATION CODES, UPDATED MANUFACTURER, UPDATED MANUFACTURER SITE.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT ID WAS NOT PROVIDED, PATIENT WEIGHT WAS NOT PROVIDED, DEVICE LOT # WAS NOT PROVIDED/UNKNOWN. ADDITIONAL 510K CODES: K013227, K953101.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CAME TO THE CLINICIAN WITH A GAP BETWEEN THE ABUTMENT AND THE CROWN. WHEN DOCTOR CHECKED THE CROWN HE REALIZED THAT THE ABUTMENT WAS UNSCREWED. IMPLANT HAD BEEN PLACED AROUND TWELVE YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814158 ABUT GOLD FRICTION-FIT 4. 5MM IMP ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR