BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 4. 5MM IMP

    MDR report key: 9920752 · Received April 3, 2020

    Report

    Report Number
    0002023141-2020-00697
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Report Date
    June 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
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ABUTMENT GOLD (HLA4G) WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES. FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED. NO PRE-EXISTING CONDITIONS WERE NOTED. THE REPORTED DEVICE HAD BEEN PLACED ON AN UNKNOWN TOOTH LOCATION FOR AN UNKNOWN AMOUNT OF TIME. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER ASSOCIATED TO THE ITEM WAS NOT PROVIDED. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER (HLA4G) WAS PERFORMED FOR SIMILAR EVENTS AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENTS COULD NOT BE VERIFIED. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. LOT/SERIAL # UNKNOWN / NOT PROVIDED. IMPLANT DATE UNKNOWN / NOT PROVIDED . EXPLANT DATE UNKNOWN / NOT PROVIDED. K013227, K953101. DEVICE MANUFACTURER DATE NUMBER UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REP THAT PATIENT HAS A HEALING ABUTMENT THAT COMES LOOSE WON¿T SEAT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387251 ABUT GOLD FRICTION-FIT 4. 5MM IMP DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention