BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 11503413 · Received March 17, 2021

    Report

    Report Number
    0002023141-2021-00648
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    October 20, 2020
    Report Date
    April 23, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM (TSVWB8) WAS NOT RETURNED FOR INVESTIGATION. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM # (IFU/RMF). PRE-EXISTING PATIENT CONDITION NOTED ON THE PER WAS SMOKER/TOBACCO USE. THE REPORTED DEVICE WAS BEING PLACED ON TOOTH # 3 (UNIVERSAL) WHEN THE INCIDENT OCCURRED AND THE IMPLANT HAD BEEN PLACED FOR ABOUT 11 MONTHS 4 DAYS. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (DAMAGED THREAD). X-RAY WAS PROVIDED. PLEASE SEE ATTACHED IMAGE 1_XRAY. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1221084. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1221084) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K011028, K013227.

    Description of Event or Problem · 1

    ORIGINAL COMPLAINT HISTORY: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS SOMETHING IN THE CHAMBER OF THE IMPLANT THAT IS PREVENTING THE RESTORATIVE DDS TO SEAT THE CROWN. PATIENT WILL RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #3. CUSTOMER RESPONDED TO REQUEST FOR ADDITIONAL INFORMATION TO PROVIDE AN XRAY AND REQUEST A RETHREADING TOOL. CUSTOMER ALSO RESPONDED STATING THAT IT WAS CONFIRMED NOTHING TO BE IN THE CHAMBER OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399630 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB8 1221084 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention