BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 13064285 · Received December 22, 2021

    Report

    Report Number
    3007700286-2021-00134
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 17, 2021
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    UDI-DI
    00851085007343
    PMA / PMN Number
    K193524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICES WERE OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR: NOT INSTALLING THE IMPLANTS FULLY ACROSS THE SI JOINT. ADDITIONALLY, PER THE SURGICAL TECHNIQUE MANUAL, THE SURGEON IS INSTRUCTED AS FOLLOWS: "PRIOR TO CLOSURE, ALWAYS OBTAIN FINAL FLUOROSCOPIC IMAGES IN THE LATERAL, INLET, AND OUTLET VIEWS TO CONFIRM NO CORTICAL WALL BREACH, FORAMEN BREACH, OR OTHER MALPOSITION."

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICES WERE OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR: NOT INSTALLING THE IMPLANTS FULLY ACROSS THE SI JOINT. ADDITIONALLY, PER THE SURGICAL TECHNIQUE MANUAL, THE SURGEON IS INSTRUCTED AS FOLLOWS: "PRIOR TO CLOSURE, ALWAYS OBTAIN FINAL FLUOROSCOPIC IMAGES IN THE LATERAL, INLET, AND OUTLET VIEWS TO CONFIRM NO CORTICAL WALL BREACH, FORAMEN BREACH, OR OTHER MALPOSITION."

    Description of Event or Problem · 0

    THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE NOT POSITIONED FULLY ACROSS THE SI JOINT. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANTS AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE ALSO IMPACTED THE SECOND IMPLANT FURTHER ACROSS JOINT. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS WERE REDUCED FOLLOWING THE REVISION PROCEDURE.

    Description of Event or Problem · 0

    THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE NOT POSITIONED FULLY ACROSS THE SI JOINT. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANTS AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE ALSO IMPACTED THE SECOND IMPLANT FURTHER ACROSS JOINT. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS WERE REDUCED FOLLOWING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958228 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. 7040M-90 9033341 00851085007343

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other