BEUDAMED
    FDA Adverse Event Summary report: N

    MAKO STRAIGHT SAW ATTACHMENT

    MDR report key: 12916962 · Received December 1, 2021

    Report

    Report Number
    MW5105731
    Date Received
    December 1, 2021
    Date of Event
    November 30, 2021
    Report Date
    November 30, 2021
    Manufacturer
    STRYKER IRELAND LTD., INSTRUMENTS DIVISION CARRIGTWOHILL
    Product Code
    OJP
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STRYKER MAKO STRAIGHT SAW ATTACHMENT WOULD NOT OSCILLATE THE BLADE. DEFECTIVE ATTACHMENT GIVEN TO STRYKER REPRESENTATIVE (B)(6) FOR EXCHANGE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811977 MAKO STRAIGHT SAW ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT OJP STRYKER IRELAND LTD., INSTRUMENTS DIVISION CARRIGTWOHILL 212186 35090421

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male