BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SACROFUSE

    MDR report key: 8642661 · Received May 24, 2019

    Report

    Report Number
    3005977257-2019-00006
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    January 30, 2018
    Report Date
    May 24, 2019
    Manufacturer
    SPINEFRONTIER INC
    Product Code
    OUR
    PMA / PMN Number
    K150017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SPINEFRONTIER INVESTIGATION INTO THIS MATTER DETERMINED THAT THE ROOT CAUSE OF THIS OCCURRENCE WAS DIRECTLY RELATED TO USER BECOMING FAMILIARIZED WITH THE SYSTEM. THIS WAS THE SURGEON'S FIRST CASE USING SPINEFRONTIER SACROFUSE POSTERIOR APPROACH TECHNIQUE. THIS CASE WAS FURTHER COMPLICATED BY THE PATIENT ANATOMY LOW POSTERIOR SUPERIOR ILIAC SPINE (PSIS), WHICH CAUSED THE BONE NEEDLE TO SLIP DOWN THE ILIUM WHEN TRYING TO START TRAJECTORY DUE TO LOW (PSIS). THIS CHALLENGE WAS EXACERBATED BY THE SURGEON'S DESIRE TO ATTEMPT AN ALMOST PERCUTANEOUS APPROACH VIA A SMALLER INCISION THAN WHAT'S PRESCRIBED IN THE SURGICAL TECHNIQUE WHICH LEAD TO HIGHER TISSUE FORCES WHICH PULL THE BONE NEEDLE OFF TRAJECTORY. SPINEFRONTIER PRODUCT DEVELOPMENT TEAM FOLLOWED-UP WITH THE SURGEON TO DISCUSS OPPORTUNITIES FOR IMPROVEMENT, DURING THE FOLLOW-UP THE SURGEON RELAYED THAT HE SUBSEQUENTLY RECOGNIZES THAT THE STARTING POINT IS CRITICAL, AND CONCUR THIS IS PART OF HIS LEARN CURVE.

    Description of Event or Problem · 1

    SPINEFRONTIER RECEIVED INFORMATION STATING THAT THE SURGEON ENCOUNTERED DIFFICULTIES ACHIEVING TRAJECTORY DURING HIS FIRST SPINEFRONTIER SACROFUSE POSTERIOR APPROACH CASE DUE TO THE BONE NEEDLE KEPT SLIPPING DOWN THE ILIUM WHEN TRYING TO START TRAJECTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436246 SACROFUSE SACROFUSE OUR SPINEFRONTIER INC 01-42202-50 BF01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention