BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 14M M HEXAGON

    MDR report key: 8164560 · Received December 14, 2018

    Report

    Report Number
    0002023141-2018-00953
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 12, 2018
    Report Date
    April 4, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A TAPERED SWISSPLUS IMPLANT (SPMB14) WAS RETURNED. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED NO EVIDENCE OF ANY DAMAGE OR MALFUNCTION. THE IMPLANT PACKAGING WAS NOT RETURNED FOR INSPECTION. THEREFORE, BASED ON THE EVALUATION, THE REPORTED EVENT COULD NOT BE VERIFIED BASED ON THE INFORMATION AVAILABLE. THE COMPLAINT ALLEGES A PACKAGING ISSUE THAT CANNOT BE FUNCTIONALLY EVALUATED. THEREFORE, NO ADDITIONAL TESTING WAS PERFORMED. REVIEW OF THE DHR FOR LOT NUMBER DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING NONCONFORMITIES/DEVIATION OR MATERIAL DEFICIENCIES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. LOT WAS INSPECTED AND ACCEPTED BY QA. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. A SINGULAR ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510K NUMBERS: K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE IMPLANT (SPMB14) WAS RECEIVED, THE STERILE BLISTER WAS FOUND TO BE OPENED. THE SURGERY WAS NOT STARTED. THE DOCTOR DID NOT KEEP THE PACKAGING. TOOTH LOCATION 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005964 IMPL TAPERED SP 3.7MM 14M M HEXAGON DENTAL IMPLANT DZE ZIMMER DENTAL 63648615

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR