BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE ORTHOCASE

    MDR report key: 5684213 · Received May 26, 2016

    Report

    Report Number
    2183926-2016-00589
    Event Type
    Malfunction
    Date Received
    May 26, 2016
    Date of Event
    April 26, 2016
    Report Date
    April 26, 2016
    Manufacturer
    MERGE HEALTHCARE, AN IBM COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K022881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER INVESTIGATION, IT WAS FOUND THE CUSTOMER WAS USING 3 DIFFERENT SIZE BALLS DURING THEIR X-RAY OF A PATIENT'S HIP. THESE BALLS WERE TAPED TO THE CUSTOMER TO PROVIDE A MEASUREMENT SCALE FOR THE TEMPLATE. WHEN THE IMAGES WERE UPLOADED TO THE TEMPLATE, IT WAS FOUND THE TEMPLATE TOOK THE AVERAGE OF THE DIFFERENT SIZE BALLS TO CALCULATE A MEASUREMENT. THIS RESULTED IN THE TEMPLATE PRODUCING INCORRECT MEASUREMENTS PRIOR TO SURGERY. THESE TEMPLATES ARE DESIGNED TO HELP THE SURGEON PLAN FOR SURGERY USING IMPLANTS. DURING SURGERY, IT WAS FOUND THE MEASUREMENTS FROM THE TEMPLATE DID NOT MATCH THE ACTUAL MEASUREMENTS IN SURGERY. THIS WAS AN INCONVENIENCE TO THE SURGEON. THERE WAS NO IMPACT TO SURGERY, AND THE CUSTOMER CONFIRMED SURGERY WAS SUCCESSFUL.

    Additional Manufacturer Narrative · 1

    AFTER FURTHER INVESTIGATION, IT WAS FOUND THE CUSTOMER WAS USING DIFFERENT SIZE BALLS WHICH CAUSED THE TEMPLATE TO NOT PRODUCE CORRECT MEASUREMENTS. NO ADDITIONAL CORRECTIVE ACTIONS ARE NEEDED.

    Description of Event or Problem · 1

    MERGE ORTHOCASE IS USED FOR ORTHOPEDIC APPLICATIONS AND CONSISTS OF FEATURES THAT ALLOW THE QUALIFIED MEDICAL PROFESSIONAL TO MAKE MEASUREMENTS THAT ARE COMMONLY REQUIRED WHEN DOING ORTHOPEDIC SURGICAL PLANNING. ON (B)(6) 2016 A CUSTOMER REPORTED INCORRECT MEASUREMENTS FROM THE TEMPLATE IN MERGE ORTHOCASE. THE CUSTOMER USED THE TEMPLATE TO MEASURE AN AREA FOR SURGERY AND WHAT SIZE IMPLANTS WILL BE USED. DURING THE SURGERY THEY FOUND THAT AREA THEY MEASURED ON THE IMAGE WAS OFF 4-6 MM. THIS EVENT WAS HIGHLY DETECTABLE BY THE SURGEON AND HE WAS ABLE TO RE-MEASURE AND USE CORRECT SIZE IMPLANT. THIS ISSUE HAS A POTENTIAL FOR USE OF AN INCORRECTLY SIZED IMPLANT DURING ORTHOPEDIC SURGERY. THE CUSTOMER CONFIRMED THE SURGERY WAS SUCCESSFUL AND THERE WAS NO HARM TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335846 MERGE ORTHOCASE MERGE ORTHOCASE LLZ MERGE HEALTHCARE, AN IBM COMPANY MERGE ORTHOCASE 3.7.2.869

    Patients

    Seq Age Sex Outcome Treatment
    1