BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 8587460 · Received May 7, 2019

    Report

    Report Number
    3007700286-2019-00056
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 3, 2019
    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 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 IMPLANT LOOSENING AFTER THE PATIENT FELL. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 2ND (SECOND): IFUSE IMPLANT, P/N 7040-90, LOT# 7550002440003, MFD. 04/25/11, EXP. 2014-04-25, (B)(4); 3RD (INFERIOR): IFUSE IMPLANT, P/N 7035-90, LOT# 7550002440002, MFD. 04/27/11, EXP. 2014-04-27, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2011 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD A PERIOD OF SI JOINT PAIN RELIEF BEFORE COMPLAINING OF A RECURRENCE OF PAIN AFTER A FALL. THE SURGEON DETERMINED THAT THAT THE 2ND AND 3RD IMPLANTS MAY HAVE BEEN LOOSE AND TOO DORSAL BASED ON LUCENCY OBSERVED ON X-RAYS. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED BOTH IMPLANTS USING CHISELS AND THEN ADDED TWO NEW IMPLANTS OF THE SAME TYPE IN MORE VENTRAL POSITIONS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382269 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 Other