BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTILE GUIDANCE SYSTEM

    MDR report key: 1668533 · Received February 17, 2010

    Report

    Report Number
    3005985723-2010-00001
    Event Type
    Injury
    Date Received
    February 17, 2010
    Date of Event
    January 6, 2010
    Report Date
    February 17, 2010
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    HAW
    PMA / PMN Number
    K072806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS ASSOCIATED WITH A PROCEDURE IN WHICH AN IMPLANT SYSTEM THAT IS MFG BY A MEDICAL DEVICE COMPANY, (B) (4), AND DISTRIBUTED BY MAKO SURGICAL CORP., IS IMPLANTED UTILIZING THE TGS. NO EVAL WAS EXECUTED ON THE TGS INVOLVED; INDICATIONS ARE THE SYSTEM PERFORMED SAFELY AND EFFECTIVELY. THE EXPLANTED COMPONENTS WERE NOT RETURNED AND ARE NOT CURRENTLY AVAILABLE. IF THEY ARE DELIVERED TO MAKO, THEY WILL BE PASSED ON TO THE MFR FOR EVAL. MAKO SURGICAL IS FILING THIS MDR TO ENSURE VISIBILITY TO A REVISION THAT OCCURRED AS A RESULT OF A PROCEDURE THAT UTILIZED A TGS.

    Description of Event or Problem · 1

    REVISION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TACTILE GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL CORP. 00040TAS00000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention