BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER HANDLE OFFSET

    MDR report key: 23744703 · Received December 8, 2025

    Report

    Report Number
    3005985723-2025-00582
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 8, 2025
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032142
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAVE BEEN OTHER COMPLAINTS WITH SIMILAR EVENT(S) FOR THE LOT REFERENCED.

    Description of Event or Problem · 0

    SPD FOUNDER CLAM SHELL SCREW MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446881 REAMER HANDLE OFFSET ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 5757427 00848486032142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown