BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 8446256 · Received March 22, 2019

    Report

    Report Number
    3007700286-2019-00021
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    February 21, 2019
    Report Date
    February 28, 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 USER ERROR: IMPROPER IMPLANT SIZE SELECTION AND POOR IMPLANT PLACEMENT. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7060-100, LOT# 493442, MFD. 03 JUL 15, EXP. 2020-07-03, (B)(4); 2ND (MIDDLE): IFUSE IMPLANT, P/N 7030-100, LOT# 222252, MFD. 21 JAN 15, EXP. 2020-01-21, (B)(4); 3RD (INFERIOR): IFUSE IMPLANT, P/N 7035-100, LOT# 493435, MFD. 27 JUL 15, EXP. 2020-07-27, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF NO PAIN RELIEF. THE SURGEON DETERMINED THAT THE CRANIAL AND CAUDAL POSITIONED IMPLANTS WERE POSITIONED TOO POSTERIOR AND THAT THE MIDDLE IMPLANT WAS TOO SHORT. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED ALL IMPLANT WITH CHISELS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238102 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other