BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2994323 · Received March 4, 2013

    Report

    Report Number
    3007700286-2013-00016
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 4, 2013
    Manufacturer
    S-BONE
    Product Code
    OUR
    PMA / PMN Number
    K122074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, REVIEW OF SURGEON TRAINING DIDACTIC, CERTIFICATES OF CONFORMANCE, IFU AND FMEA, THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS A MALPOSITIONED THIRD IMPLANT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE SURGEON PERFORMED A LEFT SI JOINT ARTHRODESIS UTILIZING THE IFUSE IMPLANT SYSTEM PLACING THREE IMPLANTS. THE SURGERY WAS UNCOMPLICATED. POST-OPERATIVELY, THE PATIENT WAS COMPLAINING OF PAIN IN THE BUTTOCK, POSTERIOR THIGH AND LOW BACK AREAS. THE PAIN WAS DIFFERENT THAN THE SI JOINT PAIN THAT THE PATIENT WAS EXPERIENCING PRE-OPERATIVELY (THE PATIENT'S SI JOINT PAIN WAS SIGNIFICANTLY IMPROVED). THE SURGEON FELT THAT THE PATIENT'S PAIN WAS RADICULAR IN NATURE. THE PATIENT'S PAIN DID NOT IMPROVE OVER TIME. THE SURGEON OBTAINED A CT SCAN THAT SHOWED THAT THE THIRD IMPLANT WAS POSITIONED TOO FAR MEDIALLY AND WAS IMPINGING ON THE SECOND NEUROFORAMEN. THE PATIENT HAD NO DOCUMENTED NEUROLOGIC WEAKNESS OR NUMBNESS IN THE LOWER EXTREMITIES. ON (B)(6) 2013, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE THIRD IMPLANT THAT WAS IMPINGING ON THE SECOND NEUROFORAMEN. THE SURGEON DID NOT PLACE GRAFT MATERIALS INTO THE DEFECT CREATED BY THE IMPLANT REMOVAL. THE PATIENT'S RADICULAR PAIN HAS RESOLVED AFTER THE REVISION SURGERY. PER DR. (B)(4) (SI-BONE VP OF MEDICAL AFFAIRS), "THIS IS A CASE OF EARLY SYMPTOMATIC MALPOSITION OF THE THIRD IMPLANT. THE MALPOSITION DIRECTION WAS MEDIAL INTO THE SECOND NEUROFORAMEN. THE PATIENT HAD NO PERMANENT NEUROLOGIC DEFICIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91441 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR S-BONE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention