BEUDAMED
    FDA Adverse Event Death Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 9745009 · Received February 24, 2020

    Report

    Report Number
    3007700286-2020-00021
    Event Type
    Death
    Date Received
    February 24, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 20, 2020
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    UDI-DI
    00851085007558
    PMA / PMN Number
    K190230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE GUIDE, IFU, CERTIFICATES OF ANALYSIS AND FMEAS, THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. THE EVENT WAS PROCEDURAL. THE MOST PROBABLE ROOT CAUSE IS THE ADULT SPINAL DEFORMITY SURGERY PROCEDURE ITSELF, NOT THE SI JOINT IMPLANT PLACEMENT.

    Description of Event or Problem · 1

    THE ELDERLY PATIENT UNDERWENT A LENGTHY SPINAL DEFORMITY SURGERY INCLUDING THE BILATERAL INSTALLATION OF TWO SI JOINT IMPLANTS. THE PATIENT SUFFERED EXTENSIVE BLOOD LOSS DURING THE PROCEDURE. THE PATIENT CODED ON THE TABLE AT THE END OF THE CASE, WAS RESUSCITATED THEN CODED AGAIN WITHOUT RESUSCITATION. MEDICAL OPINION OF CHIEF MEDICAL OFFICER: "THE SI JOINT IMPLANTS AND THE PORTION OF THE OVERALL SURGICAL PROCEDURE TO PLACE THE SI JOINT IMPLANTS ARE NOT RELATED TO PATIENT MORTALITY. THE BLEEDING IN THIS CASE (THE PRIMARY CAUSATIVE FACTOR) WAS A RESULT OF THE SPINAL DEFORMITY SURGERY, INCLUDING THE SPINAL OSTEOTOMIES. THERE IS NOT TYPICALLY A SIGNIFICANT AMOUNT OF BLEEDING ASSOCIATED WITH PLACEMENT OF S2AI SCREWS WITH OR WITHOUT THE CONCOMITANT PLACEMENT OF SI JOINT IMPLANTS. THERE WAS NO SIGNIFICANT BLEEDING REPORTED IN THIS CASE THAT WAS DIRECTLY RELATED TO THE PLACEMENT OF THE SI JOINT IMPLANTS. WHEN SI JOINT IMPLANTS ARE PLACED IN CONJUNCTION WITH S2AI SCREWS, IT TYPICALLY TAKES AN ADDITIONAL 10 MINUTES PER IMPLANT. THIS ADDITIONAL TIME IS NOMINAL COMPARED TO THE MANY HOURS TAKEN TO PERFORM THE SPINAL DEFORMITY SURGERY. IT IS NOTED THAT THE SURGEON DID REVISE THE POSITION OF THE S1 PEDICLE SCREWS, THE S2AI SCREWS AND THE SI JOINT IMPLANTS. THIS DID ADD ADDITIONAL TIME TO THE CASE. HOWEVER, THE REVISION OF THE S1 PEDICLE SCREWS WAS IN NO WAY RELATED TO THE PLACEMENT OF THE SI JOINT IMPLANTS. THE TIME TO REVISE THE S1 PEDICLE SCREWS AND THE SECOND O-ARM SPIN WOULD HAVE BEEN PERFORMED WHETHER THE SI JOINT IMPLANTS WERE PLACED OR NOT. THE INITIAL POSITION OF THE S2AI SCREWS MAY OR MAY NOT HAVE BEEN RELATED TO THE SUBSEQUENT PLACEMENT OF THE SI JOINT IMPLANTS. IN SUMMARY, ADULT SPINAL DEFORMITY SURGERY CARRIES A HIGH RISK OF MORBIDITY AND MORTALITY. IT IS UNLIKELY THAT THE PROCEDURE TO PLACE SI JOINT IMPLANTS IN CONJUNCTION WITH S2AI PELVIC FIXATION IN THIS CASE SIGNIFICANTLY INCREASED THE RISK OF BLEEDING OR SIGNIFICANTLY LENGTHENS THE PROCEDURE. AS SUCH, PLACEMENT OF THE SI JOINT IMPLANTS IN THIS CASE OR IN SPINAL DEFORMITY CASES IN GENERAL IS LOW RISK AND WOULD, IN MOST CASES, BE UNRELATED TO MORBIDITY ASSOCIATED WITH THE SPINAL DEFORMITY SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210107 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. 7080M-90 2656281 00851085007558

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death