BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 9779440 · Received March 3, 2020

    Report

    Report Number
    0002023141-2020-00472
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 10, 2020
    Report Date
    May 8, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE REPORTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE DEVICE HAD BEEN PLACED ON AN UNKNOWN TOOTH LOCATION FOR AN UNKNOWN PERIOD OF TIME. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. A YEAR-LONG COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS PERFORMED FOR SIMILAR EVENTS AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. COMPLAINANT REPORTED THAT THE ABUTMENT LOOSENED. THE PRODUCT WAS NOT RETURNED; THE REPORTED COMPLAINT COULD NOT BE VERIFIED DUE TO LACK OF DEFINITIVE EVIDENCE. A ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED, AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED, PATIENT SEX UNKNOWN / NOT PROVIDED, WEIGHT UNKNOWN / NOT PROVIDED, LOT NUMBER UNKNOWN / NOT PROVIDED, LAST NAME UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER: K011028 / K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT HAS LOOSENED AND WILL NOT STAY TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244867 ABUT GOLD FRICTION-FIT 3. 5MM IMP ABUTMENT SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1