BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT

    MDR report key: 23411408 · Received October 29, 2025

    Report

    Report Number
    3001617766-2025-006547
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    March 20, 2025
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACT
    Product Code
    DZE
    PMA / PMN Number
    K130572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DI # (B)(4). CORRECTION: PART # 653713, DI # (B)(4), 510K # K130572.

    Description of Event or Problem · 0

    LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718913 INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT ENDOSSEOUS DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACT 150816

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention