BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWPLANT IMPLANT

    MDR report key: 11848569 · Received May 19, 2021

    Report

    Report Number
    3001617766-2021-02796
    Event Type
    Injury
    Date Received
    May 19, 2021
    Report Date
    April 11, 2022
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307104933
    PMA / PMN Number
    K061319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION. UPDATED SECTION B4 FOR REPORT SUBMISSION DATE AND B6 TO REPORT DEVICE EVALUATION RESULTS. UPDATED D9 FOR DEVICE RETURN DATE, G1 FOR FOLLOW-UP REPORT SUBMITTER, G3 FOR AWARENESS DATE AND G6 FOR REPORT TYPE AND FOLLOW-UP NUMBER. UPDATED H2 FOR FOLLOW-UP TYPE, H3 FOR DEVICE EVALUATION STATUS AND H6 METHOD, RESULT AND CONCLUSION CODES. THIS COMPLAINT IS BEING SUBMITTED LATE DUE TO THE FURLOUGHS THAT RESULTED FROM THE GLOBAL PANDEMIC AND IS CAPTURED WITHIN DEVIATION 1412.

    Additional Manufacturer Narrative · 1

    PATIENT'S IDENTIFIER, AGE, WEIGHT, DATE OF EVENT, OTHER RELEVANT HISTORY AND INCLUDING PREEXISTING MEDICAL CONDITIONS WERE NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. IMPLANT DATE AND EXPLANT DATE IS UNKNOWN. LOT INFORMATION IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTARY REPORT WILL BE SUBMITTED. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS COMPLAINT IS BEING SUBMITTED LATE DUE TO THE FURLOUGHS THAT RESULTED FROM THE GLOBAL PANDEMIC AND IS CAPTURED WITHIN DEVIATION 1412.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747189 SCREWPLANT IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA NI 10841307104933

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention