BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTILE GUIDANCE SYSTEM

    MDR report key: 1071760 · Received June 26, 2008

    Report

    Report Number
    3005985723-2008-00005
    Event Type
    Malfunction
    Date Received
    June 26, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 26, 2008
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    HAW
    PMA / PMN Number
    K072806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL SURGERY WAS INLAY PROCEDURE. TIBIAL RIM WAS COMPROMISED DURING CEMENTING AND IMPACTING, SO PROCEDURE WAS CONVERTED TO ONLY USING ALTERNATIVE SYSTEM AS REQUEST OF SURGEON. THE TGS SOFTWARE DOES NOT DIRECTLY SUPPORT THIS TYPE OF CONVERSION. SURGEON CHOSE TO PLAN THE ONLAY, WHICH WAS NOT IMPLANTED INTO INTENDED POSITION. DUE TO LACK OF MOTION FROM PATIENT, SURGEON CHOSE TO REVISE TO ANOTHER ONLAY, THE FOLLOWING DAY. CURRENT INFORMATION AND ACCOUNT RECOLLECTION FROM SURGEON AND MAKO PERSONNEL INVOLVED INDICATES THAT THE SYSTEM OPERATED AS EXPECTED, WITH NO FAILURES. ROOT CAUSE WAS INABILITY TO PROPERLY PLAN, BASED ON SURGEON DECISION TO CONVERT FROM INLAY SYSTEM TO A DIFFERENT ONLAY SYSTEM.

    Description of Event or Problem · 1

    DR. STATED THAT HIS PATIENT WAS UNABLE TO PUT HER LEG INTO EXTENSION WITHOUT PAIN. HE STATED THAT A FOLLOW-UP X-RAY SHOWED THAT THE ENCORE TIBIAL ONLAY IMPLANT "WAS APPROXIMATELY 5MM TOO FAR POSTERIOR AND 2MM TOO MEDIAL." HE WAS GOING TO REVISE THE PATIENT IN 2008, WITH A MANUAL ENCORE TIBIAL ONLAY. THE PATIENT WAS ORIGINALLY PLANNED FOR A STELKAST FEMUR AND STELKAST INLAY TIBIAL IMPLANT (MEDIAL). AFTER THE POSTERIOR TIBIAL WALL OF THE TIBIA WAS DAMAGED WHILE CEMENTING THE INLAY TIBIA, HE OPTED TO CONVERT TO AN ENCORE ONLAY TIBIAL IMPLANT. HE ALSO STATED (TODAY 2008) THAT HE FELT THAT THE REASON THAT HE HAD DAMAGED THE POSTERIOR TIBIAL WALL (WHILE IMPLANTING THE INLAY TIBIA) WAS BECAUSE THE ROBOT WAS "CUTTING TOO DEEP POSTERIORLY THE WHOLE TIME." PT HAD REVISION SURGERY THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TACTILE GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL CORP. 0040TAS00000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other ENCORE EPIC ONLAY SYSTEM| STELKAST UNI-KNEE SYSTEM