BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 9234206 · Received October 24, 2019

    Report

    Report Number
    3007700286-2019-00118
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    October 2, 2019
    Report Date
    October 21, 2019
    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 ANALYSIS AND FMEAS, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE FOR THE RECURRENCE OF PAIN IS THE PATIENT'S FALL. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANTS AT THE PATIENT'S REQUEST. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7055-100, LOT# 493583, MFD. 15 OCT 15, EXP. 2020-10-15, GTIN (B)(4); 2ND (SECOND): IFUSE IMPLANT, P/N 7045-100, LOT# 493836, MFD. 24 FEB 17, EXP. 2022-02-24, GTIN (B)(4); 3RD (INFERIOR): IFUSE IMPLANT, P/N 7030-100, LOT# 222252, MFD. 21 JAN 15, EXP. 2020-01-21, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD PAIN RELIEF FOR ONE YEAR BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN AFTER A FALL FROM A LADDER. A DIFFERENT SURGEON THOUGHT THAT THE IMPLANTS LOOKED WELL POSITIONED WITH POSSIBLY ONLY THE INFERIOR POSITIONED IMPLANT NOT BEING FULLY ACROSS THE SI JOINT. THE PATIENT REQUESTED THAT ALL THE IMPLANTS BE REMOVED. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THE IMPLANTS WITH CHISELS. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026649 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention