BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 7157475 · Received January 2, 2018

    Report

    Report Number
    3007700286-2017-00145
    Event Type
    Injury
    Date Received
    January 2, 2018
    Date of Event
    December 15, 2017
    Report Date
    December 28, 2017
    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 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 IS INCORRECT IMPLANT PLACEMENT, PLACING THE IMPLANT TOO DEEP. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7070-100, LOT# 175692, MFD: 11 JUL 14, EXPIRES 2019-07, (B)(4); 2ND (MIDDLE): IFUSE IMPLANT, P/N 7060-100, LOT# 444533, MFD: 18 MAR 15, EXPIRES 2020-03, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT'S SI JOINT PAIN FELT BETTER FOR THREE DAYS FOLLOWING THE INITIAL PROCEDURE, BUT LATER COMPLAINED OF RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MOST CRANIAL POSITIONED LEFT SIDE IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE CRANIAL AND MIDDLE IMPLANTS USING CHISELS AS THEY WERE BOTH SOLIDLY FIXED IN BONE. HE THEN PLACED TWO NEW IFUSE IMPLANTS IN DIFFERENT POSITIONS AND FILLED THE EXPLANT HOLES WITH BONE GRAFT. NO OTHER IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention