BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2896505 · Received December 28, 2012

    Report

    Report Number
    3007700286-2012-00082
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 28, 2012
    Manufacturer
    SIBONE
    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

    PRODUCT WAS RETURNED FOR HISTOLOGY ANALYSIS BY HISTION (THIRD PARTY ANALYSIS LAB) 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, 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 RIGHT SI JOINT FUSION UTILIZING THREE IFUSE IMPLANTS ON (B)(6) 2012. PATIENT HAD GOOD PAIN RELIEF FOR 6 MONTHS AND THEN BEGAN TO DEVELOP PAIN SIMILAR TO HER PRE-OP PAIN. THE SURGEON BELIEVED THAT THERE WAS LUCENCY AROUND THE MIDDLE IMPLANT MEDIALLY AND PLANNED TO REMOVE THE MOST INFERIOR AND MIDDLE IMPLANT AND LEAVE THE SUPERIOR IMPLANT IN PLACE. HE PLANNED ON REPLACING THE IFUSE IMPLANTS WITH 2 GLOBUS SI-LOK 12 MM SCREWS. HE ATTEMPTED TO REMOVE THE MIDDLE IMPLANT USING OSTEOTOMES BUT WAS UNSUCCESSFUL IN MOVING THE IMPLANT BASED ON FLUORO. THE SURGEON DECIDED TO LEAVE IT IN PLACE. HE REMOVED THE INFERIOR IMPLANT WHICH LOOKED VOID OF BONY INGROWTH AND PLACED A 12 MM SI-LOK SCREW IN THE HOLE LEFT BY THE IMPLANT. MEDICAL ASSESSMENT BASED ON PLAIN FILMS SHOW WHAT DOES APPEAR FO BE SCLEROTIC LOOSENING OF THE SACRAL TIP OF THE IMPLANT. THE CT SCAN DOES NOT SHOW ANY EVIDENCE OF HALO ALONG ANY OF THE IMPLANTS. THIS APPEARS TO BE THE CASE OF SYMPTOMATIC LATE LOOSENING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention