BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,10,MTX,MG

    MDR report key: 13043481 · Received December 20, 2021

    Report

    Report Number
    0002023141-2021-03692
    Event Type
    Injury
    Date Received
    December 20, 2021
    Report Date
    June 7, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019874
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) IMP,TSV,6.0,10,MTX,MG (TSVT6B10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT ATTACHED TO BUNDLED MOUNT. PRODUCT RETURNED WITHOUT ORIGINAL PACKAGING AND WITH SIGNS OF USE. FUNCTIONAL TESTING DETERMINED THE IMPLANT AND MOUNT WERE ABLE TO BE SEPARATED WITHOUT THE NEED OF EXCESSIVE FORCE, THEREFORE, NO MALFUNCTION WAS OBSERVED WITH THE REPORTED DEVICE BUNDLE. DRIED BLOOD AND OTHER DEBRIS/SIGNS OF USE WERE NOTED WITHIN THE IMPLANT DRIVE FEATURE AND ALONG THE MOUNT HEX. A PRE-EXISTING CONDITION NOTED ON THE PER WAS HIGH BONE DENSITY (TYPE I). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 19 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 2 MONTHS, AND 21 DAYS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENT REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT, ADVENT AND TRABECULAR METAL IMPLANTS, 4869 REV 9-10/19; BREAKAGE; PAGE 2. INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS. PER THE APPLICABLE IFU, UNDER SECTION WARNINGS THAT PRACTITIONERS SHOULD ATTEND COURSES OF STUDY TO FAMILIARIZE THEMSELVES WITH IMPLANTOLOGY TECHNIQUES. IMPROPER TECHNIQUE CAN CAUSE IMPLANT FAILURE. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1243724). 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 (1243724) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DOES NOT DISENGAGE/RELEASE POST MARKET TRENDING REVIEW: APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DOES NOT DISENGAGE/RELEASE) OR PRODUCT (TSVT6B10). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL 510(K) NUMBER IS K101880.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPRESSION COPING/MOUNT GOT STUCK AND COULD NOT BE REMOVED FROM IMPLANT. IMPLANT WAS REMOVED AND SITE WAS GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945523 IMP,TSV,6.0,10,MTX,MG DENTAL IMPLANT AND MOUNT DZE ZIMMER DENTAL TSVT6B10 1243724 00889024019874

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention