BEUDAMED
    FDA Adverse Event Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2875366 · Received December 13, 2012

    Report

    Report Number
    3007700286-2012-00079
    Date Received
    December 13, 2012
    Date of Event
    November 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SI-BONE INC.
    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 ON THE INFORMATION PROVIDED, REVIEW OF SURGEON TRAINING AND FMEA, THE MOST PROBABLE ROOT CAUSE FOR THE COMPLAINT IS INCORRECT IMPLANT SIZE SELECTIONS AND MALPOSITION OF THE IMPLANTS.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A RIGHT SI JOINT ARTHRODESIS UTILIZING THE IFUSE IMPLANT SYSTEM IN (B)(6) 2011. THE ISSUE IS ONE OF RECURRENT SI JOINT PAIN WITH PRESUMED PSEUDOARTHROSIS. THE PATIENT INITIALLY DID QUITE WELL WITH A MARKED IMPROVEMENT IN HER SI JOINT PAIN COMPLAINTS. THE PATIENT BEGAN TO EXPERIENCE A RECURRENCE OF HER SI JOINT PAIN APPROXIMATELY 4 TO 6 MONTHS POST SI JOINT FUSION. A CT SCAN WAS PERFORMED; THE INTERPRETATION OF THE CT SCAN WAS DESCRIBED IN THE PRIOR REPORT. "THE SCAN SHOWS THAT THE CEPHALAD IMPLANT IS IN GOOD POSITION WITH GOOD BONE APPOSITION IN BOTH THE ILIAC AND THE SACRAL BONES. THIS IMPLANT IS A BIT PROUD LATERALLY. THE MIDDLE IMPLANT IS ALSO PROUD LATERALLY, IT IS SOLIDLY FIXED IN THE ILIUM, AND THERE IS SUGGESTION OF A HALO AT THE TIP OF THIS IMPLANT WHERE IT ABUTS INTO THE SACRUM. THE THIRD IMPLANT IS PROUD LATERALLY, THIS IMPLANT APPEARS TO CROSS THE SI JOINT, BUT APPEARS TO HAVE MINIMAL PURCHASE INTO THE SACRUM (PARTICULARLY ON THE AXIAL VIEW)". THE PATIENT DID RESPOND FAVORABLE TO AN SI JOINT DIAGNOSTIC INJECTION. ON (B)(6) 2012, DR (B)(6) PERFORMED A REVISION SURGERY ON THIS PATIENT. AT SURGERY THE SURGEON ATTEMPTED TO REMOVE THE THIRD IMPLANT WITH HOPES OF REPLACING IT WITH A LONGER IMPLANT. DR (B)(6) WAS UNABLE TO REMOVE THE THIRD IMPLANT WITH THE THREADED REMOVAL DEVICE AND THE SLAP HAMMER. DR (B)(6) DID NOT ATTEMPT TO USE AN OSTEOTOME. DR (B)(6) LEFT THE IMPLANT IN PLACE. HE THEN PLACED A NEW IMPLANT DISTAL/CAUDAL TO THE EXISTING THIRD IMPLANT. THIS IMPLANT WAS A 7 X 40 MM IMPLANT. HE ALSO PLACED A NEW 4 X 40 MM IMPLANT JUST DORSAL TO AND SOMEWHAT CEPHALAD TO THE THIRD IMPLANT. THE PATIENT HAD NO NEW PAIN COMPLAINTS AFTER THIS PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention