BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 3.7MM MTX,13MM

    MDR report key: 15130477 · Received July 29, 2022

    Report

    Report Number
    0002023141-2022-01931
    Event Type
    Injury
    Date Received
    July 29, 2022
    Date of Event
    April 21, 2022
    Report Date
    January 4, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018884
    PMA / PMN Number
    K132258
    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). PATIENT WEIGHT NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D4: EXPIRATION DATE AND UDI G3: DATE RECEIVED BY THE MANUFACTURER H1: TYPE OF REPORT, FOLLOW-UP NUMBER H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES' H4: DEVICE MANUFACTURE DATE H6: EVALUATION CODES H10: ADDITIONAL NARRATIVE ONE IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE IMPLANT WAS FRACTURED AT THE BODY. ZIMVIE IS NOT RESPONSIBLE FOR ANY DAMAGE CAUSED BY THE CLINICIAN'S REMOVAL OF THE DEVICE. 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 IV). THE REPORTED DEVICE WAS LOCATED ON TOOTH 33 (FDI) AND WAS USED FOR APPROXIMATELY 1 YEARS, 11 MONTH(S). X-RAY & PICTURE EVALUATION: THE CUSTOMER DID NOT PROVIDE ANY IMAGES FOR THE REPORTED EVENT. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS (IFU4869 REV 9-10/19) INFORMATION IDENTIFIED: 'CONTRAINDICATIONS' 'WARNINGS' & 'PRECAUTIONS' DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1230732. 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1230732 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: 'DENTAL : FUNCTIONAL : FRACTURE : IMPLANT' POST MARKET TREND REVIEW: OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED AS PHYSICAL EVALUATION IDENTIFIED THE FRACTURED IMPLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT HAD TO BE REMOVED DUE TO BECOMING FRACTURED. A NEW IMPLANT WAS PLACED AFTER REMOVAL.

    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
    2425247 IMP TM 3.7MM MTX,13MM DENTAL IMPLANT DZE ZIMMER DENTAL TMMB13 1230732 00889024018884

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention