BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY2 SBM IMPLANT 5.2DX11L 4.5MMD PLAT

    MDR report key: 23533738 · Received November 12, 2025

    Report

    Report Number
    3001617766-2025-008935
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 13, 2025
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACT
    Product Code
    DZE
    UDI-DI
    10841307101444
    PMA / PMN Number
    K192221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEWED ATTACHED CUSTOMER FEEDBACK FORM: (B)(4) CONTRAINDICATIONS RELEVANT TO FAILURE: COMPONENT DOES NOT DISENGAGE. PART NUMBER: 825211 REVISION: C VISUAL: CONTAMINATED CONDITION. RECEIVED 825211 ASSY. IN AN OPENED VIAL. IT WAS DIFFICULT TO BREAK THE FIXATION SCREW LOOSE. ONCE THE SCREW WAS BROKEN LOOSE AND THE ASSEMBLY WAS TAKEN APART, A THIN FILM OF DRIED BLOOD / SALIVA COULD BE SEEN INSIDE THE BORE OF THE TRANSFER. DRIED BLOOD ACTS AS A GLUE OR SEALANT THUS POTENTIALLY LOCKING THE SCREW IN PLACE. THE ASSEMBLY WAS REASSEMBLED AND DISASSEMBLED MULTIPLE TIMES WITH NO TROUBLE OR EFFORT. SEE PHOTOS. COMPLAINT IS NOT CONFIRMED. SPECIFICATION SHOULD BE: LENGTH: .463 SPECIFICATION AS FOUND: .463 DIAMETER: .2021/.2036 SPECIFICATION AS FOUND: .2026 COMMENTS: RBS (B)(6) 2025.

    Description of Event or Problem · 0

    COMPONENT DOES NOT DISENGAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933269 LEGACY2 SBM IMPLANT 5.2DX11L 4.5MMD PLAT ENDOSSEOUS DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACT 15025410 10841307101444

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention