BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 3.7MM 8MM OCTAGON

    MDR report key: 9807494 · Received March 9, 2020

    Report

    Report Number
    0002023141-2020-00508
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    February 4, 2020
    Report Date
    March 9, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA 510(K): K011245, K002188. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A CRATERIZATION WITH ABSCESS AND INFLAMMATION. TOOTH LOCATION 18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268060 IMPL TAPERED SP 3.7MM 8MM OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL 64057711

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention