BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 11240577 · Received January 27, 2021

    Report

    Report Number
    3007700286-2021-00003
    Event Type
    Injury
    Date Received
    January 27, 2021
    Date of Event
    January 5, 2021
    Report Date
    January 26, 2021
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K190230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AND THE PATIENT'S OBESE CONDITION. MODEL NUMBER, LOT NUMBER, MANUFACTURE DATE, GTIN: IFUSE-3D IMPLANT, P/N 7070M-90, LOT# 2738291, MFD.07/29/20, EXP. 2025-07-29, GTIN (B)(4). IFUSE-3D IMPLANT, P/N 7070M-90, LOT# 2760621, MFD.10/20/20, EXP. 2025-10-20, GTIN (B)(4).

    Description of Event or Problem · 1

    THERE WAS NO PROBLEM WITH DEVICE OR THE PLACEMENT OF THE SI JOINT IMPLANTS. THE PATIENT HAD BILATERAL SI JOINT FUSION IN CONJUNCTION WITH A SPINAL LONG CONSTRUCT IN (B)(6) 2020. THE PATIENT LATER DEVELOPED AN INFECTION AT THE SURGERY SITE. APPROXIMATELY TWO WEEKS FOLLOWING THE INITIAL PROCEDURE, THE SURGEON DEBRIDED AND IRRIGATED THE WOUND SITE AND BEGAN TREATMENT WITH IV ANTIBIOTICS. THIS EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132943 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O| R