BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 9272281 · Received November 4, 2019

    Report

    Report Number
    3007700286-2019-00128
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    October 9, 2019
    Report Date
    October 28, 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 IS USER ERROR: INITIAL IMPLANT MALPOSITIONING. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: IFUSE IMPLANT, P/N 7050-90, LOT# 7550002452006, MFD. UNKNOWN, EXP. 2014-04, GTIN (B)(4), IFUSE IMPLANT, P/N 7040-90, LOT# 7550002440003, MFD. UNKNOWN, EXP. 2014-04, GTIN (B)(4), IFUSE IMPLANT, P/N 7035-90, LOT# 7550002440002, MFD. UNKNOWN, EXP. 2014-04, GTIN (B)(4), IFUSE IMPLANT, P/N 7045-90, LOT# 8078003696004, MFD. UNKNOWN, EXP. 2015-08, GTIN (B)(4), IFUSE IMPLANT, P/N 7055-90, LOT# 8028003235006, MFD. UNKNOWN, EXP. 2015-04, GTIN (B)(4), IFUSE IMPLANT, P/N 4045-90, LOT# 7551002779010, MFD. UNKNOWN, EXP. 2015-05, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2011 AND (B)(6) 2012. SIX IMPLANTS IN TOTAL WERE INSTALLED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH PAIN COMPLAINTS. THE SURGEON BELIEVED THAT FOUR OF THE SIX WERE MALPOSITIONED AND TOO CLOSE TO THE S1 NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON REMOVED FOUR OF THE SIX IMPLANTS WITH CHISELS. TWO OF THE IMPLANTS WERE LEFT IN PLACE. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067269 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention