BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2875173 · Received December 12, 2012

    Report

    Report Number
    3007700286-2012-00073
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SI-BONE
    Product Code
    OUR
    PMA / PMN Number
    K080398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE COMPLAINT INFORMATION AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL, CERTIFICATE OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE OR THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS PLACEMENT OF THE IMPLANTS THROUGH THE ILIAC DEFECT AND INCORRECT IMPLANT SIZE SELECTIONS.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A SI JOINT FUSION UTILIZING THREE IFUSE IMPLANTS ON (B)(6) 2011. THE PT HAD GOOD RELIEF FROM SI JOINT PAIN FOR SIX MONTHS AT WHICH TIME SHE BEGAN TO EXPERIENCE PAIN THAT WAS TYPICAL IN NATURE AND IN LOCATION TO THE PAIN SHE WAS EXPERIENCING BEFORE HER IFUSE SURGERY. THE PAIN CONTINUED TO WORSEN OVER THE NEXT SEVERAL MONTHS. NO REPEAT DIAGNOSTIC INJECTION WAS PERFORMED. IMAGING SHOWED HALOS AROUND ALL THREE IMPLANTS PARTICULARLY ON THE LATERAL VIEW. THE CT SCAN SHOWED LUCENCY ON THE ILIAC SIDE OF THE FIRST TWO IMPLANTS AND AROUND THE SACRAL SIDE OF THE THIRD IMPLANT. THE PT HAD A PRIOR ILIAC CREST GRAFT HARVESTED FROM THE IPSILATERAL ILIUM. THE IMPLANTS ARE PLACED THROUGH THE ILIAC DEFECT. THE PT ALSO HAD A PRIOR MULTILEVEL LUMBAR FUSION. ON (B)(6) 2012, THE SURGEON PERFORMED A REVISION SURGERY TO REMOVE ALL THREE IMPLANTS. THE IMPLANTS CAME OUT EASILY WITHOUT THE USE OF OSTEOTOMES. THERE WAS VERY LITTLE BONE ADHERENT TO THE IMPLANTS. THE SURGEON THEN REPLACED THE REMOVED IFUSE IMPLANTS WITH TWO 12 MM GLOBUS SI-LOK SCREWS. THE PT HAD NO RADICULAR PAIN COMPLAINTS AND NO NEUROLOGIC DEFICITS AFTER THE INDEX IFUSE SURGERY OR AFTER THE REVISION PROCEDURE. SI-BONE'S VP OF MEDICAL AFFAIRS MADE THE FOLLOWING ASSESSMENT, "THE PT IS AT HIGH RISK FOR OSTEOPOROSIS/OSTEOPENIA BECAUSE OF HER AGE AND ETHNICITY. IT IS UNKNOWN IF PT WAS USING MEDICATION THAT COULD INHIBIT BONE HEALING OR FUSION. THE DEFECT IN THE ILIUM FROM PRIOR BONE GRAFT HARVEST IS A RISK FACTOR. THE OVERALL SHORT LENGTH OF THE IMPLANTS IS A RISK FACTOR AS WELL."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention