BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 15845417 · Received November 22, 2022

    Report

    Report Number
    0002023141-2022-02921
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 21, 2022
    Report Date
    March 14, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019225
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) NUMBER UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: D6A. IF IMPLANTED, CHANGED TO UNKNOWN. ONE (1) IMP,TSV,4.1MM,SBM,10 (TSV4B10) WAS RETURNED FOR INVESTIGATION. A FRACTURED PORTION OF THE UNKNOWN ZIMMER SCREW WAS RETURNED INSIDE THE IMPLANT. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE. THE IMPLANT FRACTURED AT THE COLLAR AND THE FRACTURED SCREW WAS INSIDE THE IMPLANT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY (TYPE III). THE REPORTED IMPLANT WAS LOCATED ON TOOTH # 46 (FDI) AND WAS USED FOR APPROXIMATELY 6 YEARS. THE LENGTH OF THE SCREW USAGE IS UNKNOWN. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1243652). 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, WERE 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 (1243652) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE IMPLANT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENTS WERE CONFIRMED FOLLOWING VISUAL EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A FRACTURED AT THE COLLAR.

    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
    2707425 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B10 1243652 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention