BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2932342 · Received January 24, 2013

    Report

    Report Number
    3007700286-2013-00005
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 24, 2013
    Manufacturer
    SI-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 AND FMEA, THE MOST PROBABLE ROOT CAUSE IS THAT THE IMPLANT WAS MALPOSITIONED MEDIALLY TO THE S1 FORAMEN.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE SURGEON PERFORMED A RIGHT ARTHRODESIS USING THREE IFUSE IMPLANTS. THERE WERE NO INTRA-OPERATIVE CHALLENGES OR COMPLICATIONS. THE PATIENT INITIALLY HAD NO NEW PAIN COMPLAINTS AND NO NEW COMPLAINTS OF NUMBNESS OR WEAKNESS IN THE LOWER EXTREMITIES. SEVERAL DAYS AFTER SURGERY, THE PATIENT BEGAN TO DEVELOP RADIATING RIGHT LEG PAIN THAT GRADUALLY INCREASED OVER THE NEXT SEVERAL MONTHS. THE PATIENT NEVER HAD SIGNIFICANT NUMBNESS OR WEAKNESS. IMAGING SHOWED THAT THE SECOND IMPLANT WAS VERY NEAR THE GRADUALLY FORAMEN. THE PATIENT'S SYMPTOMS DID NOT IMPROVE. THE SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2012 TO REMOVE THE SECOND IMPLANT. THE SURGEON HAD DIFFICULTY REMOVING THE IMPLANT AND GRAFTED THE HOLE CREATED BY REMOVAL OF THE IMPLANT WITH PIONEER SURGICAL'S NANOSS PRODUCT (DBM AND ALLOGRAFT). AT THE FIRST POST-OPERATIVE VISIT, THE PATIENT IS MUCH IMPROVED AND THE RADIATING RIGHT LEG PAIN IS COMPLETELY GONE. THERE IS NO RESIDUAL NUMBNESS OR WEAKNESS. SI-BONE'S VP OF MEDICAL AFFAIRS MADE THE FOLLOWING ASSESSMENT, "THIS IS A CASE OF MALPOSITION OF THE SECOND IMPLANT. THE IMPLANT WAS MALPOSITIONED MEDIALLY TO THE SI FORAMEN WITH RESULTANT RADIATING LEG PAIN RESULTING FROM IMPINGEMENT/IRRITATION OF THE NERVE SECONDARY TO THE IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34845 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR SI-BONE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention