BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 4002298 · Received August 12, 2014

    Report

    Report Number
    3007700286-2014-00096
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    March 30, 2012
    Report Date
    October 10, 2014
    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

    THESE REPORTABLE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE AND PATIENT INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFORMATION ON INDIVIDUAL EVENTS. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO SI-BONE. IFUSE IMPLANTS WERE USED IN ALL OF THE MIS CASES. PUBLICATION: MINIMALLY INVASIVE VERSUS OPEN SACROILIAC JOINT FUSION. CHARLES G. T. LEDONIO, M.D, DAVID W. POLLY JR MD, MARC F. SWIONTKOWSKI MD, CLINICALORTHOPAEDICS AND RELATED RESEARCH®EDICAL DEVICES, DOI 10.1007/S11999-014-3499-8, 12 FEB 2014.

    Additional Manufacturer Narrative · 1

    ONE OF THE COMPLICATION NOTED IN THE PAPER WAS A PULMONARY EMBOLISM: PER THE SURGEON'S PA "THE PATIENT DEVELOPED SOMNOLENCE AND LETHARGY POST-OPERATIVELY. FOUND PE ON POST-OP DAY #3. TREATED WITH ENOXAPARIN IN THE HOSPITAL AND WENT HOME ON WARFARIN. WITHIN 1 DAY OF DISCHARGE, HE DEVELOPED INTENSE RIGHT LEG PAIN AND WAS FOUND TO HAVE A DVT AND HAD AN IVC FILTER PLACED (B)(6) 2012. NO FURTHER ISSUES WITH BLOOD CLOT, NO FURTHER SURGERIES." PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES AND EXPIRATION DATES: IFUSE IMPLANT, P/N 7040-90, LOT# 7663002731003, MANUFACTURED 06/27/11, EXPIRES 2014-10, IFUSE IMPLANT, P/N 7050-90, LOT# 7628002578005, MANUFACTURED 07/26/11, EXPIRES 2014-07, IFUSE IMPLANT, P/N 7055-90, LOT# 7753003041004, MANUFACTURED 11/28/11, EXPIRES 2015-01 (X2).

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A STUDY OF 44 PATIENTS THAT UNDERWENT MINIMALLY INVASIVE SURGERY (MIS) USING THE IFUSE SYSTEM OR HAD OPEN SI JOINT SURGERY. THE SOURCE LITERATURE REPORTED THAT THREE PATIENTS HAD COMPLICATIONS POSSIBLY RELATED TO THE MIS PROCEDURE INCLUDING ONE CASE OF PULMONARY EMBOLISM THAT RESOLVED WITH TREATMENT AND TWO REVISIONS DUE TO HALO FORMATION ON THE SACRAL SIDE. THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED ABOUT THESE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480730 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R