BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ROB333 17060X 2X9MM LM BASE PLATE TRIAL

    MDR report key: 8666697 · Received June 4, 2019

    Report

    Report Number
    3005985723-2019-00412
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 4, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    WHEN RESETTING THE TRAY THE 2 LM X 9 MM BASEPLATE TRIAL WAS SEVERELY DAMAGED AND NOT CAPABLE OF BEING USED IN FUTURE CASES. CASE TYPE: PKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458681 UNKNOWN ROB333 17060X 2X9MM LM BASE PLATE TRIAL KNEE IMPLANT JWH MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other