BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7, 10, MTXF, MG,HA

    MDR report key: 13904879 · Received March 25, 2022

    Report

    Report Number
    0002023141-2022-00724
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Report Date
    September 7, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344341
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). DATE OF EVENT: EVENT DATE NOT PROVIDED. PMA/510K: ADDITIONAL 510(K) NUMBER IS K133339.

    Additional Manufacturer Narrative · 0

    AN IMP, TSV, 4.7, 10, MTXF, MG,HA (TSVTWH10) WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE LOCATION WAS #14 AND LENGTH OF USAGE IS APPROXIMATELY 3 YEARS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR SCREW-VENT® IMPLANTS (9665 REV 0-09/14) INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, BREAKAGE DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (63810097). 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (63810097) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FUNCTIONAL : DAMAGED THREADS. POST MARKET TREND REVIEW: JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. SECTIONS UPDATED: B4: DATE OF THIS REPORT. G3: DATE INVESTIGATION RESULTS WERE RECEIVED. G6: TYPE OF REPORT AND FOLLOW UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED. H6: ADVERSE EVENT PROBLEM CODES. H10: MANUFACTURER'S NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THREADS OF THE IMPLANT ARE DAMAGED AND THE CUSTOMER IS REQUESTING A RETHREADING TOOL TO RETHREAD THE IMPLANT. TOOTH #14.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277363 IMP, TSV, 4.7, 10, MTXF, MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWH10 63810097 00889024344341

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose