BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT

    MDR report key: 15084320 · Received July 22, 2022

    Report

    Report Number
    0001038806-2022-01122
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    June 21, 2022
    Report Date
    December 29, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER UNKNOWN. MANUFACTURING DATE UNKNOWN.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE UNKNOWN ZIMMER IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED FRACTURE AT THE COLLAR WITH SCREW FRAGMENT INSIDE. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS FRACTURED. PRE-EXISTING CONDITION NOTED ON THE PER WAS "MODERATE BONE DENSITY ¿ TYPE II". THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH #46 (FDI). X-RAY PICTURE PROVIDED IN PER WITH IMPLANT SHOWN PLACED IN PATIENT¿S MOUTH. DEVICE HISTORY RECORD (DHR), STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED. PAIN WAS A CONSEQUENCE OF THE EVENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108982 DENTAL IMPLANT DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention