BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2903440 · Received January 2, 2013

    Report

    Report Number
    3007700286-2012-00084
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 3, 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 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 LATE SYMPTOMATIC LOOSENING.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A LEFT SI JOINT ARTHRODESIS UTILIZING THE IFUSE IMPLANT SYSTEM ON (B)(6) 2012. THE SURGEON PLACED THREE IMPLANTS; 7 X 50, 7 X 30 (2ND) AND 7 X 45MM. APPROXIMATELY 6 MONTHS AFTER THE INDEX OPERATION, THE PATIENT BEGAN HAVING PAIN IN THE LEFT SI JOINT AREA. THE PAIN WAS OF SIMILAR NATURE, AND IN THE SAME AREA AS BEFORE SURGERY. WORKUP INCLUDED A CT SCAN WHICH THE SURGEON FELT SHOWED LUCENCY AROUND THE ILIAL PORTION OF THE FIRST IMPLANT. HE FELT THAT THE FIRST IMPLANT WAS SHORT AND DORSAL OF THE SI JOINT. HE FELT THE THIRD IMPLANT WAS IN GOOD POSITION BETWEEN THE FIRST AND THE SECOND FORAMEN. ON (B)(6) 2012, THE SURGEON PERFORMED A REVISION SURGERY. DURING SURGERY, HE USED THE SI-BONE REMOVAL DEVICE TO REMOVE THE CEPHALAD IMPLANT. IT TOOK 10 MINUTES OF AGGRESSIVE POUNDING WITH THE SLOTTED MALLET TO REMOVE THE IMPLANT. HE THEN REPEATED THE REMOVAL PROCESS FOR THE SECOND IMPLANT. HE POUNDED IN THE IMPLANT FOR FIFTEEN MINUTES BUT WAS UNABLE TO REMOVE THE SECOND IMPLANT. HE LEFT THE IMPLANT IN PLACE. HE PLACED A 7 X 60MM IMPLANT VENTRAL TO THE PREVIOUSLY PLACED 2ND IMPLANT. HE THEN PLACED A 7 X 35 MM IMPLANT DISTAL TO THE PREVIOUSLY PLACED 3RD IMPLANT. THE SURGEON DID NOT PLACE ANY GRAFT MATERIAL INTO THE HOLE CREATED BY THE REMOVAL OF THE CEPHALAD IMPLANT. THE SURGEON THEN OPENED THE JOINT FROM A DORSAL APPROACH AND PLACED BONE GRAFT. THERE WERE NO COMPLICATIONS RELATED TO THE SURGERY. THE PATIENT HAD NO NEW SYMPTOMS AFTER THE SURGERY. THIS IS A CASE OF SYMPTOMATIC LATE LOOSENING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention