BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1,10,MTX,MG

    MDR report key: 12923401 · Received December 3, 2021

    Report

    Report Number
    0002023141-2021-03468
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    September 1, 2021
    Report Date
    May 18, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019829
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4)ONE (1) IMP,TSV,4.1,10,MTX,MG (TSVT4B10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT WITH ORIGINAL PACKAGING ATTACHED TO THE BUNDLED MOUNT. NO SIGNS OF USE OBSERVED ON THE IMPLANT. STERILE BARRIER BROKEN. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1233728). 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 WAS PERFORMED FOR THE REPORTED LOT NUMBER (1233728) FOR SIMILAR EVENT USING KEYWORD INCORRECT COMPONENT QUANTITY AND NO OTHER COMPLAINT WAS IDENTIFIED. KEYWORDS: INCORRECT COMPONENT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE DENTAL SURGICAL PROCEDURE HE REALIZED THAT THE IMPLANT CONTAINER WAS EMPTY. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

    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
    1824348 IMP,TSV,4.1,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B10 1233728 00889024019829

    Patients

    Seq Age Sex Outcome Treatment
    1 Male