BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1,13,MTX,MG

    MDR report key: 14681125 · Received June 13, 2022

    Report

    Report Number
    0002023141-2022-01483
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 5, 2022
    Report Date
    November 28, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019843
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    AN IMP,TSV,4.1,13,MTX,MG (TSVT4B13) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SLIGHT DEBRIS ON THREADS. NO DAMAGE IDENTIFIED. PRE-EXISTING CONDITIONS NOTED ON THE PER IS DIABETES. THE REPORTED DEVICE LOCATION WAS #13 AND LENGTH OF USAGE IS APPROXIMATELY 2 DAYS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1250616). 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 (1250616) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. SEP 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 NOT OCCUR, AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED IMPLANT STRIPPED DURING INSERTION. TOOTH 13.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990750 IMP,TSV,4.1,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B13 1250616 00889024019843

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention