BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    MDR report key: 19056524 · Received April 6, 2024

    Report

    Report Number
    0002023141-2024-01083
    Event Type
    Injury
    Date Received
    April 6, 2024
    Date of Event
    February 18, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020054
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER#: 1253743. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED, AS PART OF THE DHR. STERILIZATION RECORD OP# 150, STR2 WAS REVIEWED AND VERIFIED, TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER#: 1253743, FOR SIMILAR EVENTS. AND TWO OTHER COMPLAINTS WERE IDENTIFIED ((B)(4)). REVIEW COMPLETED UTILIZING KEYWORDS: INFECTION 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. H3 OTHER TEXT: SUMMARY INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER ¿ K013227. 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 · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #36, WITH ASSOCIATED PAIN. THEREFORE, THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782939 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1253743 00889024020054

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention