BEUDAMED
    FDA Adverse Event Other Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3210830 · Received July 2, 2013

    Report

    Report Number
    3007700286-2013-00042
    Event Type
    Other
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SI-BONE
    Product Code
    OUR
    PMA / PMN Number
    K123850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS SENT FOR HISTOLOGY ANALYSIS BY (B)(4) (THIRD PARTY ANALYSIS LABORATORY) TO ASSESS BONY IN-GROWTH. NO STRUCTURAL ANALYSIS IS PERFORMED. BASED UPON THE COMPLAINT INFORMATION AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL, IFU, CERTIFICATES OF ANALYSIS AND FMEA, THE ROOT CAUSE IS PAIN CAUSED BY MALPOSITIONED IMPLANTS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE SURGEON PERFORMED A RIGHT SIDE SI JOINT IFUSE PROCEDURE ON THE PATIENT PLACING THREE IFUSE IMPLANTS. THE PATIENT DID WELL FOR A FEW MONTHS AFTER THE SURGERY, BUT LATER FELL AND STARTED HAVING PAIN ON HER RIGHT (OPERATIVE) SIDE. A CT SCAN REVEALED THAT THE HER RIGHT (OPERATIVE) SIDE. A CT SCAN REVEALED THAT THE BOTTOM IMPLANT WAS SITTING IN SOFT TISSUE RATHER THAN BONE. IN ADDITION, THE SECOND IMPLANT WAS APPROXIMATELY ONLY THREE MILLIMETERS ACROSS THE JOINT. ON (B)(6) 2013, THE SURGEON PERFORMED A REVISION SURGERY TO EXTRACT THE BOTTOM IMPLANT AND ADVANCED THE SECOND IMPLANT AN ADDITIONAL 5 MM ACROSS THE JOINT. X-RAYS CONFIRMED PROPER PLACEMENT OF THE IMPLANTS. PER SI-BONE VP OF MEDICAL AFFAIRS, "THE REASON FOR THE REVISION SURGERY IS LATE RECURRENCE OF PAIN. CT EVALUATION SHOWS THAT THE SECOND IMPLANT IS SHORT AND BARELY ACROSS THE JOINT AND THAT THE THIRD IMPLANT IS NOT SEATED INTO THE SACRUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301726 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR SI-BONE 7035-90 8028003323002

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention