BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,4.1MM,8MM

    MDR report key: 9286208 · Received November 6, 2019

    Report

    Report Number
    0002023141-2019-01027
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    September 18, 2019
    Report Date
    January 7, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP,TSV,MCOL MG,4.1MM,8MM (TSVM4B8) WAS RETURNED FOR INVESTIGATION (IMAGE 1-2). VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED A SIGNIFICANT AMOUNT OF DEBRIS ABOUT THE IMPLANT THREADS. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING PD-TSVM4B8 REV D. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 19 (FDI) AND USED FOR APPROXIMATELY 2 MONTHS. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1223376. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, 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 (1223376) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (BONE LOSS) OR PRODUCT (TSVM4B8). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT (TSVM4B8) WAS REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082235 IMP,TSV,MCOL MG,4.1MM,8MM DENTAL IMPLANT DZE ZIMMER DENTAL 1223376

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention