BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 9558704 · Received January 7, 2020

    Report

    Report Number
    3007700286-2019-00158
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    December 19, 2019
    Report Date
    January 2, 2020
    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 IS USER ERROR; IMPLANT MALPOSITIONING DURING INSTALLATION. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7055-100, LOT# 493439, MFD. 16 JUL 15, EXP. 2020-07-16, GTIN (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7050-100, LOT# 493438, MFD. 24 JUL 15, EXP. 2020-07-24, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7040-100, LOT# 493436, MFD. 30 JUL 15, EXP. 2020-07-30, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD PAIN RELIEF FOR ONE YEAR AFTER THE INITIAL PROCEDURE BEFORE REPORTING A RECURRENCE OF RIGHT SI JOINT PAIN SYMPTOMS TO A NEW SURGEON WHO DETERMINED THAT ALL THE IMPLANTS WERE SLIGHTLY MALPOSITIONED DORSALLY. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANTS WITH CHISELS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22716 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention