BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2922339 · Received January 11, 2013

    Report

    Report Number
    3007700286-2013-00001
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 11, 2013
    Manufacturer
    SI-BONE
    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 UPON THE COMPLAINT INFO AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL AND FMEA, THE MOST PROBABLE ROOT CAUSE IS SYMPTOMATIC LATE LOOSENING OF THE SI JOINT RESULTING FROM THE PT'S FALL.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED AN SI JOINT FUSION SURGERY UTILIZING THE IFUSE IMPLANT SYSTEM ON (B)(6) 2012. THE PT HAD BEEN INJURED AT WORK. SHE RESPONDED FAVORABLY TO A DIAGNOSTIC INJECTION. THE SURGERY WAS PERFORMED WITHOUT COMPLICATION. THE PT HAD NO NEW PAIN COMPLAINTS, AND NO NEW NEUROLOGIC COMPLAINTS OF NUMBNESS OF WEAKNESS. THE PT HAD MARKED IMPROVEMENT OF HER SI JOINT PAIN. THE PT DID WELL UNTIL (B)(6) 2012 WHEN THE PT SLIPPED AND FELL LANDING ON HER BUTTOCKS. THE PT FELT A POP IN HER IPSILATERAL GLUTEAL/SI AREA. THE PT HAD IMMEDIATE RETURN TO HER ORIGINAL SI PAIN. THE PAIN WAS SIMILAR IN NATURE AND ANATOMIC LOCATION AS WAS HER PAIN PRIOR TO THE SACROILIAC JOINT FUSION. THE SURGEON WAS OF THE OPINION THAT THE PAIN WAS COMING FROM THE SI JOINT. THE SURGEON DID NOT PERFORM A REPEAT DIAGNOSTIC INJECTION. THE REVISION SURGERY ON (B)(6) 2012 CONSISTED OF AN OPEN POSTERIOR APPROACH TO THE SI JOINT. HE THEN DECORTICATED THE ARTICULAR SURFACE OF THE JOINT. HE PLACED LOCAL AUTOGRAFT AND A SMALL BMP SPONGE. THE SURGEON DID NOT REMOVE ANY OF THE PREVIOUSLY PLACED IFUSE IMPLANTS. THE SURGEON DID NOT PLACE ANY ADDITIONAL IFUSE IMPLANTS. THE SURGEON DID NOT PLACE ANY ADDITIONAL INSTRUMENTATION. THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE REVISION SURGERY. SI-BONE'S VP OF MEDICAL AFFAIRS MADE THE FOLLOWING ASSESSMENT, "THIS IS A CASE OF SYMPTOMATIC LATE LOOSENING OF THE SI JOINT. THERE WAS A SIGNIFICANT TRAUMATIC EVENT ASSOCIATED WITH THE RECURRENCE OF THE PT'S PAIN RESULTING FROM THE PT'S FALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18978 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR SI-BONE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention