BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3863038 · Received June 10, 2014

    Report

    Report Number
    3007700286-2014-00077
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K080398
    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 GUIDE, CERTIFICATES OF ANALYSIS, IFU AND FMEA, THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS A MALPOSITIONED IMPLANT. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES AND EXPIRATION DATES FOR IFUSE IMPLANTS ADDED ON (B)(4) 2014: IFUSE IMPLANT, P/N 7045-90, LOT# I0898, MANUFACTURED 12/23/13, EXPIRES 2018-12; IFUSE IMPLANT, P/N 7045-90, LOT# I0899, MANUFACTURED 12/27/13, EXPIRES 2018-12; IFUSE IMPLANT, P/N 7050-90, LOT# I0863, MANUFACTURED 06/27/13, EXPIRES 2018-11; IFUSE IMPLANT, P/N 7065-90, LOT# 8047003938017, MANUFACTURED 08/23/12, EXPIRES 2015-10.

    Description of Event or Problem · 1

    IN (B)(6) 2014, THE SURGEON PERFORMED A RIGHT SIDE IFUSE PROCEDURE ON THE PATIENT PLACING FOUR IFUSE IMPLANTS. THE PATIENT HAD LEG PAIN FOLLOWING THE INITIAL SURGERY. CT SCANS SHOWED THAT THE SUPERIOR IMPLANT HAD BREACHED THE NEUROFORAMEN. A FEW DAYS LATER, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REPOSITIONED THE FIRST IMPLANT BY BACKING IT OUT A FEW MILLIMETERS. NO IMPLANTS WERE REMOVED. THE PATIENT'S SYMPTOMS RESOLVED AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338556 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention