BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 3.7MM 8MM OCTAGON

    MDR report key: 10441847 · Received August 24, 2020

    Report

    Report Number
    0002023141-2020-01288
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    May 15, 2020
    Report Date
    August 24, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017207
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: 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 AN INFECTIOUS PROCESS OCCURRED AT TOOTH LOCATION # 25. THE PATIENT HAS PAIN AND THE IMPLANT IS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908047 IMPL TAPERED SP 3.7MM 8MM OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPB8 62741073 00889024017207

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention