BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2896514 · Received December 28, 2012

    Report

    Report Number
    3007700286-2012-00083
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 28, 2012
    Manufacturer
    SIBONE
    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 UPON THE COMPLAINT INFORMATION AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE OR THAT THE DEVICE WAS OUT OF SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS LATE SYMPTOMATIC LOOSENING.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A RIGHT SI JOINT FUSION USING THE IFUSE IMPLANT SYSTEM ON (B)(6) 2011. DUE TO PERCEIVED ANATOMICAL LIMITATIONS, THE SURGEON PLACED ONLY 2 IMPLANTS. THE PATIENT INITIALLY DID QUITE WELL AND HAD SIGNIFICANTLY LESS SI JOINT PAIN AFTER THE SI JOINT FUSION. AT APPROXIMATELY 6 MONTHS AFTER THE INDEX FUSION, THE PATIENT BEGAN TO HAVE PAIN THAT WAS SIMILAR IN NATURE AND LOCATION AS HER SI JOINT PAIN BEFORE THE FUSION. THE SI JOINT PAIN PROGRESSIVELY WORSENED. ON (B)(6) 2012, THE SURGEON PERFORMED A REVISION SURGERY. THE SURGEON ACCESSED THE LATERAL ASPECT OF THE ILIUM. HE PLACED THE REMOVAL DEVICE INTO EACH OF THE TWO PREVIOUSLY PLACED IFUSE IMPLANTS. BOTH IMPLANTS WERE SOLID. NEITHER IMPLANT MOVED, EVEN WITH VIGOROUS HAMMERING WITH THE SLAP HAMMER. THE SURGEON LEFT THE IMPLANTS IN PLACE. THE SURGEON THEN PLACED A 4 X 40 MM IMPLANT A BIT VENTRAL AND SOMEWHAT IN BETWEEN THE TWO PREVIOUSLY PLACED IMPLANTS. HE ALSO PLACED A 7 X 35 MM IMPLANT AT THE BASE OF THE SACRUM, DISTAL TO THE PREVIOUSLY PLACED SECOND IMPLANT. THE SURGEON THEN PERFORMED AN OPEN POSTERIOR APPROACH TO THE SI JOINT. HE ACCESSED THE INFERIOR ASPECT OF THE JOINT BY REMOVING A SMALL PIECE OF THE ILIAC CREST. HE DECORTICATED THE JOINT WITH A BURR AND PLACED AN EXTRA SMALL BMP SPONGE INTO THE JOINT ALONG WITH THE PIECE OF THE ILIAC CREST AUTO GRAFT. THE PATIENT DID WELL AFTER THE PROCEDURE. THE PATIENT HAD NO NEW PAIN COMPLAINTS AND NO NEW NEUROLOGIC COMPLAINTS. THIS IS A CASE OF SYMPTOMATIC LATE LOOSENING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention