BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 9234412 · Received October 24, 2019

    Report

    Report Number
    3007700286-2019-00125
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 21, 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 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 LATE LOOSENING. PART NUMBERS, LOT NUMBERS, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7055-90, LOT# 493875, MFD. 04/10/17, EXP. 2022-04-10, GTIN (B)(4). 2ND (SECOND): IFUSE IMPLANT, P/N 7045-90, LOT# 493979, MFD. 08/10/17, EXP. 2022-08-10, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7045-90, LOT# 493979, MFD. 08/10/17, EXP. 2022-08-10, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD TEN MONTHS OF PAIN RELIEF BEFORE REPORTING A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON BELIEVED THERE WERE HALOS (LOOSENING) AROUND THE IMPLANTS. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE MALPOSITIONED. IN (B)(6) 2019, THE SURGEON REMOVED ALL THREE IMPLANTS USING CHISELS AND INSTALLED NEW HARDWARE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028336 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other