BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 11574096 · Received March 26, 2021

    Report

    Report Number
    0001038806-2021-00493
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    February 2, 2021
    Report Date
    August 2, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE UNKNOWN LB SCREW WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES TO ADDRESS REPORTED EVENT. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE ITEM/LOT NUMBER ASSOCIATED WITH THE REPORTED DEVICE WAS NOT AVAILABLE. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS WITHIN SPECIFICATIONS. COMPLAINT HISTORY COULD NOT BE PERFORMED AS THE ITEM/LOT NUMBER OF THE REPORTED DEVICE WAS NOT AVAILABLE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENTS COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NON-VERIFIABLE AND THE PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT REFERRED HAVING A LOOSE CROWN. PATIENT ALSO LOST THE IMPLANT. CROWN AND IMPLANT WERE REMOVED. PATIENT WOULD RESCHEDULED FOR NEW IMPLANTATION. CROWN HAD BEEN PLACED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475319 DENTAL SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR