BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 9690484 · Received February 10, 2020

    Report

    Report Number
    3007700286-2020-00006
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 10, 2020
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K190230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 INCORRECT DIAGNOSIS. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANTS AT THE PATIENT'S REQUEST. PART NUMBERS, LOT NUMBERS, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7050-100, LOT# 494222, MFD. 19 AUG 2017, EXP. 2022-08-19, GTIN (B)(4). 2ND (SECOND): IFUSE IMPLANT, P/N 7040-100, LOT# 493996, MFD. 30 AUG 2017, EXP. 2022-08-30, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7040-100, LOT# 493996, MFD. 30 AUG 2017, EXP. 2022-08-30, 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 CLAIMS TO HAVE NEVER HAD PAIN RELIEF FOLLOWING THE INITIAL PROCEDURE AND WANTED THE IMPLANTS REMOVED. THE PATIENT HAD NO RADICULAR PAIN SYMPTOMS AND THE SURGEON BELIEVES THE IMPLANTS WERE WELL POSITIONED AND NOT LOOSE. IT IS LIKELY THAT IT WAS AN INCORRECT DIAGNOSIS. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THREE IMPLANTS USING CHISELS. THE EXPLANT VOIDS WERE NOT FILLED WITH BONE GRAFT OR OTHER HARDWARE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149851 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other