BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL SWISSPLUS OCTAGON 4. 1MM 10MM

    MDR report key: 11529145 · Received March 19, 2021

    Report

    Report Number
    0002023141-2021-00670
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    December 29, 2020
    Report Date
    March 19, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024015791
    PMA / PMN Number
    K011245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) NUMBER: ADDITIONAL NUMBER: 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 INFECTION AT TOOTH SITE # 14. PATIENT MENTIONED PAIN, AND INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424008 IMPL SWISSPLUS OCTAGON 4. 1MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL OPB10 63206206 00889024015791

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention