BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWINDIRECT IMPLANT

    MDR report key: 11877227 · Received May 25, 2021

    Report

    Report Number
    3001617766-2021-03019
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    February 8, 2021
    Report Date
    July 26, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307104834
    PMA / PMN Number
    K061319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED B4 FOR REPORT SUBMISSION DATE, G1 FOR CONTACT INFORMATION, G3 FOR AWARENESS DATE OF NEW INFORMATION, G6 FOR REPORT TYPE AND SECTIONS D9, H1, H2, H3, AND H6 TO REPORT THAT THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776907 SCREWINDIRECT IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 167069 10841307104834

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention