BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 4. 5MM IMP

    MDR report key: 8656478 · Received May 30, 2019

    Report

    Report Number
    0002023141-2019-00233
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Report Date
    August 29, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ABUT GOLD FRICTION-FIT 4. 5MM IMP (HLA4G) WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 30 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 1.5 MONTHS. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE HLA4G DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/ HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. JUNE POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (LOOSENING) OR PRODUCT (HLA4G). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED.

    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 LOT NUMBER: NOT PROVIDED. PMA/510(K) NUMBER: K013227, K953101. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED A LOOSENING SCREW (HLA4G). DOCTOR REPLACED IT WITH A NEW SCREW AT THE TIME AND REUSED THE ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448207 ABUT GOLD FRICTION-FIT 4. 5MM IMP ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR