BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER

    MDR report key: 20565850 · Received October 30, 2024

    Report

    Report Number
    20565850
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 17, 2024
    Report Date
    October 18, 2024
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SCREW MISSING FROM MAKO ACETABULAR REAMER. PART NUMBER 00848486032142, LOT 5598643, OTHER #212760. MANUFACTURER RESPONSE FOR STRYKER MAKO REAMER, MAO (PER SITE REPORTER) UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891780 REAMER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 212760 559864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose