BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.7 TAPERED SCREW VENT FM T

    MDR report key: 16342266 · Received February 9, 2023

    Report

    Report Number
    0002023141-2023-00500
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    December 20, 2022
    Report Date
    May 17, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K061410
    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). ONE (1) 4.7 TAPERED SCREW VENT FM T (FMT4) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED DAMAGE A CROWN ADHERED TO THE FMT4. THE MOUNTS HEX WAS FRACTURED, AND THE FRACTURED PIECE WAS NOT RETURNED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT (FRACTURED MOUNT). A PRE-EXISTING CONDITION WAS NOT NOTED ON THE PER FORM. BONE DENSITY WAS LOW DENSITY (TYPE III). THE REPORTED DEVICE WAS LOCATED ON TOOTH #36 (FDI). THE DEVICE WAS FOR 26 DAYS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1247592. 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 1247592 FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : FRACTURE : MOUNT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PREMARKET IDENTIFICATION /K011028/K013227.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ABUTMENT FRACTURED AFTER 4 WEEKS. ABUTMENT PLACED ON (B)(6) 2022 AND REMOVED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412218 4.7 TAPERED SCREW VENT FM T DENTAL SCREW NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Female