BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3030266 · Received March 28, 2013

    Report

    Report Number
    3007700286-2013-00022
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 28, 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 DIDACTIC, CERTIFICATES OF ANALYSIS, IFU AND FMEA, THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. THE ROOT CAUSE IS MALPOSITIONED IMPLANTS IMPINGING ON THE NERVE.

    Description of Event or Problem · 1

    IN (B)(6) 2012, THE SURGEON PERFORMED A LEFT SI JOINT ARTHRODESIS UTILIZING THE IFUSE IMPLANT SYSTEM ON THE PATIENT. THE PATIENT DID QUITE WELL WITH THE PROCEDURE. THE PATIENT HAD ON GOING RIGHT SIDED SI JOINT SYMPTOMS. ON (B)(6) 2012, THE SURGEON PERFORMED A RIGHT SIDE SI JOINT ARTHRODESIS ON THE PATIENT USING THREE IFUSE IMPLANTS. THERE WERE NO INTRA OR POST-OPERATIVE COMPLICATIONS. THE PATIENT HAD GOOD RELIEF OF HER RIGHT SIDED SI JOINT PAIN AND HAD NO RADIATING PAIN INTO HER LOWER EXTREMITIES. IN (B)(6) 2013, THE PATIENT SLIPPED AND FELL LANDING ON HER RIGHT HIP AND BUTTOCK AREA. THE PATIENT EXPERIENCED LOCAL PAIN IN THE BUTTOCK AREA AND ALSO BEGAN EXPERIENCING RADIATING PAIN DOWN THE RIGHT LEG. IMAGING SHOWED THAT THE SECOND AND THE THIRD IMPLANTS WERE NOW BREACHING THE CORTEX OF THE FIRST NEUROFORAMEN. THE SURGEON STATED THAT THE IMPLANTS (RIGHT SIDE) HAD "MIGRATED." THE PATIENT DID NOT RESPOND TO PAIN MEDICATION AND A STEROID TAPER. ON (B)(6) 2013, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REPOSITIONED THE SECOND AND THE THIRD IMPLANTS (RIGHT SIDE), BACKING THEM EACH OUT APPROXIMATELY FIVE MILLIMETERS. THERE WERE NO DIFFICULTIES OR COMPLICATIONS ASSOCIATED WITH THE REVISION SURGERY. THE PATIENT NO LONGER HAD RADIATING PAIN COMPLAINTS IN HER LOWER EXTREMITIES AT FOLLOW-UP ON (B)(6) 2013. PER DR. RECKLING (SI-BONE VP OF MEDICAL AFFAIRS), "THE REVISION SURGERY WAS PERFORMED TO REPOSITION THE SECOND AND THE THIRD IMPLANTS THAT WERE MALPOSITIONED MEDIALLY. THE IMPLANTS WERE CAUSING IMPINGEMENT ON THE NERVE WITH RESULTANT RADIATING LEG PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129535 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR SI-BONE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention