BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE TORQ IMPLANT SYSTEM

    MDR report key: 21172492 · Received January 16, 2025

    Report

    Report Number
    3007700286-2024-00005
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    December 29, 2024
    Report Date
    January 16, 2025
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K203247
    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 DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE FOR THE INFECTION IS THE SURGICAL PROCEDURE OR LATER SI JOINT INJECTION. INDEX SURGERY IMPLANTS INSTALLED ON (B)(6) 2024: 1ST (SUPERIOR): IF USE TORQ IMPLANT, P/N 11565T, LOT 9082231, MFD. 04/19/2023, EXP. 2028-04-19, GTIN (B)(4); 2ND (MIDDLE): IF USE TORQ IMPLANT, P/N 11540T, LOT 9090981, MFD. 03/28/2024, EXP. 2029-03-28, GTIN (B)(4); 3RD (INFERIOR): IF USE TORQ IMPLANT, P/N 11540T, LOT 9090971, MFD. 03/28/2024, EXP. 2029-03-28, GTIN (B)(4).

    Description of Event or Problem · 0

    PER SI-BONE CHIEF MEDICAL OFFICER: THE INDEX CASE WAS A LEFT SIDED SIJ FUSION USING TORQ IN (B)(6) 2024. THE PATIENT IS A 70 YEAR OLD MALE. THE PATIENT HAD RECURRENCE OF PAIN ONE WEEK AFTER THE PROCEDURE. PAIN WAS WORSE WITH AMBULATION, BETTER WITH LYING DOWN. THE FIRST IMPLANT WAS PROUD ON FLUORO IMAGING. THE PHYSICIAN SHARED THAT THIS AREA WAS NOT OVERLY TENDER TO PALPATION. POSSIBLE REASONS FOR THE INCREASED PAIN INCLUDING THE POSSIBILITY OF A FRACTURE OF THE ILIUM AND ALSO THE POSSIBILITY OF FLUID COLLECTION SUCH AS A HEMATOMA WERE DISCUSSED WITH THE PHYSICIAN AS WELL AS A CT SCAN AS A FIRST LINE AS THIS WOULD SHOW BETTER ANATOMIC DETAIL AROUND THE IMPLANTS. THE PHYSICIAN SHARED NO ADDITIONAL INFORMATION REGARDING PATIENTS OVERALL HEALTH OR ANY SYSTEMIC COMPLAINTS. THE PATIENT WAS LATER ADMITTED TO THE HOSPITAL WITH AN ABSCESS IN (B)(6) 2024. THE PHYSICIAN HAD PERFORMED AN INJECTION INTO THE SURGICAL SITE THE WEEK PRIOR FOR ATTEMPTED PAIN CONTROL. THE INJECTION PROCEDURE WAS PERFORMED IN THE PHYSICIAN'S OFFICE. NO DETAILS REGARDING WHAT WAS INJECTED WERE SHARED. THERE WERE SOME CHALLENGES GETTING SURGICAL SUPPORT TO HELP MANAGE THE CASE. INTERVENTIONAL RADIOLOGY ATTEMPTED TO DRAIN THE ABSCESS. A SURGEON SUBSEQUENTLY DEBRIDED THE WOUND AND REMOVED THE IMPLANTS. THE PATIENT DID REQUIRE A SECONDARY HOSPITALIZATION AND AN ADDITIONAL SURGERY. MY MEDICAL OPINION IS THAT THE REPORTED INJECTION INTO THE SURGICAL SITE WAS A SIGNIFICANT CONTRIBUTING FACTOR TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893181 IFUSE TORQ IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE_SECTION_D.10 SEE_SECTION_D.10

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| O