BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1,11.5,MTX,MG

    MDR report key: 14355968 · Received May 11, 2022

    Report

    Report Number
    0002023141-2022-01149
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    August 5, 2019
    Report Date
    October 17, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019836
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). PATIENT WEIGHT NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    AN IMP,TSV,4.1,11.5,MTX,MG (TSVT4B11) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE AND FROM THE REMOVAL PROCESS. FRACTURED HEX HAS BEEN IDENTIFIED IN THE IMPLANTS DRIVE FEATURE. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE LENGTH OF USAGE OF THE DEVICE IS SAME DAY. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 9-10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, CHANGES IN PERFORMANCE, ADVERSE EFFECTS . DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1223318). 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 (1223318) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE. POST MARKET TREND REVIEW: AUG 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 DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSFER COPING FRACTURED DURING PROCEDURE, REMOVED IMPLANT W/ TREPHINE AND COMPLETED THE PROCEDURE USING A LARGER IMPLANT. TOOTH #19.

    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
    2157404 IMP,TSV,4.1,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B11 1223318 00889024019836

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male