BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 4792261 · Received May 22, 2015

    Report

    Report Number
    3007700286-2015-00034
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 27, 2015
    Report Date
    May 21, 2015
    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 SURGICAL TECHNIQUE GUIDE, IFU AND CERTIFICATES OF ANALYSIS, THE MOST PROBABLE ROOT CAUSE FOR THE DVT IS THE SURGICAL PROCEDURE. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES AND EXPIRATION DATES: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7070-90, LOT# I0A57, MANUFACTURED 07/23/14, EXPIRES 2019-07; 2ND (MIDDLE): IFUSE IMPLANT, P/N 7050-90, LOT# 223222, MANUFACTURED 12/18/14, EXPIRES 2019-12; 3RD (INFERIOR): IFUSE IMPLANT, P/N 7050-90, LOT# 292222, MANUFACTURED 12/09/14, EXPIRES 2019-12.

    Description of Event or Problem · 1

    IN (B)(6) 2015, THE SURGEON PERFORMED A LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT PLACING THREE IFUSE IMPLANTS. PATIENT COMPLAINED OF CONTRALATERAL CALF SWELLING AND PAIN APPROXIMATELY TWO WEEKS POST-OP. PATIENT TESTED POSITIVE FOR DVT AND IS CURRENTLY BEING TREATED WITH ANTICOAGULANTS BY HIS PRIMARY CARE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336952 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other