BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 8571054 · Received May 1, 2019

    Report

    Report Number
    3007700286-2019-00047
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 26, 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 LATE LOOSENING OF THE IMPLANTS. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: IFUSE IMPLANT, P/N 7050-100, LOT# 493999, MFD. 06 OCT 17, EXP. 2020-10-06, GTIN (B)(4), IFUSE IMPLANT, P/N 7060-100, LOT# 493579, MFD. 16 OCT 15, EXP. 2020-10-16, GTIN (B)(4), IFUSE IMPLANT, P/N 7045-100, LOT# 493897, MFD. 05 MAY 17, EXP. 2022-05-05, GTIN (B)(4), IFUSE IMPLANT, P/N 7045-100, LOT# 493997, MFD. 11 AUG 17, EXP. 2022-08-11, GTIN (B)(4), IFUSE IMPLANT, P/N 7055-100, LOT# 494223, MFD. 28 JUL 17, EXP. 2022-07-28, GTIN (B)(4), IFUSE IMPLANT, P/N 7050-100, LOT# 493999, MFD. 06 OCT 17, EXP. 2020-10-06, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED ON EACH SIDE. THE SURGEON DETERMINED THAT THE IMPLANTS MAY HAVE BEEN LOOSE. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE MALPOSITIONED. IN (B)(6) 2019, THE SURGEON REMOVED ALL SIX IMPLANTS AND REPLACED THEM WITH LARGER, AND WIDER, IMPLANTS OF THE SAME TYPE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363495 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other