BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER HEALING ABUTMENT

    MDR report key: 11288886 · Received February 5, 2021

    Report

    Report Number
    0002023141-2021-00314
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Report Date
    June 7, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE REPORTED DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED SINCE THE PRODUCTS WERE NOT RETURNED. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH # 4 FOR AN UNKNOWN PERIOD OF TIME. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED AND NO OTHER INFORMATION WAS PROVIDED. DHR AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. COMPLAINANT REPORTED THAT THE UNKNOWN ZIMMERBIOMET HEALING ABUTMENT FRACTURED OFF INSIDE OF AN UNKNOWN TSV IMPLANT. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. A DEFINITIVE 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 (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. BRAND NAME UNKNOWN / NOT PROVIDED. DEVICE PRODUCT CODE UNKNOWN / NOT PROVIDED. CATALOG AND LOT NUMBER UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNK ZB HEALING ABUTMENT FRACTURED OFF INSIDE OF AN UNK TSV IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186149 UNKNOWN ZIMMER HEALING ABUTMENT HEALING ABUTMENT NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR