BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 4.8MM 10M M OCTAGON

    MDR report key: 11078724 · Received December 28, 2020

    Report

    Report Number
    0002023141-2020-02407
    Event Type
    Injury
    Date Received
    December 28, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 28, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017566
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K011245/K002188. FAX NUMBER UNKNOWN / NOT PROVIDED. . 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 IN TOOTH LOCATION #15 WAS REMOVED DUE TO INFECTION. PATIENT ALSO EXPERIENCED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544063 IMPL TAPERED SP 4.8MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPWB10 2020011479 00889024017566

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention