BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 6631913 · Received June 9, 2017

    Report

    Report Number
    3007700286-2017-00042
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    May 15, 2017
    Report Date
    June 9, 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 ANALYSIS 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 THE SURGICAL PROCEDURE AND THE PATIENT'S OBESITY. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI NUMBERS: LEFT 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7055-90, LOT# 493585, MFD. 10/23/15, EXPIRES 2020-10, UDI (B)(4). LEFT 2ND (MIDDLE): IFUSE IMPLANT, P/N 7045-90, LOT# 493563, MFD. 09/08/15, EXPIRES 2020-09, UDI (B)(4). LEFT 3RD (INFERIOR): IFUSE IMPLANT, P/N 7035-90, LOT# 343335, MFD. 05/05/15, EXPIRES 2020-05, UDI (B)(4). RIGHT 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7050-90, LOT# 493587, MFD. 10/22/15, EXPIRES 2020-10, UDI (B)(4). RIGHT 2ND (MIDDLE): IFUSE IMPLANT, P/N 7040-90, LOT# 493593, MFD. 12/18/15, EXPIRES 2020-12, UDI (B)(4). RIGHT 3RD (INFERIOR): IFUSE IMPLANT, P/N 7035-90, LOT# 343335, MFD. 05/05/15, EXPIRES 2020-05, UDI (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED ON EACH SIDE. THE PATIENT IS SIGNIFICANTLY OBESE. THE PATIENT COMPLAINED OF PAIN AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THERE WERE ILIAC WING FRACTURES AND IMPLANT LOOSENING POSSIBLY CAUSED BY THE PATIENT'S OBESITY. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED FOUR OF THE SIX IMPLANTS. THE FRACTURES HEALED WITHOUT FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411356 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention