BEUDAMED
    FDA Adverse Event Death Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 4973500 · Received August 5, 2015

    Report

    Report Number
    3007700286-2015-00058
    Event Type
    Death
    Date Received
    August 5, 2015
    Date of Event
    May 6, 2013
    Report Date
    August 4, 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 THE SURGICAL TECHNIQUE GUIDE, IFU AND FMEA THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS BLEEDING AND A TOXIC LEVEL OF AN UNPRESCRIBED DRUG, TRAMADOL. PART NUMBERS AND QUANTITIES ARE NOT KNOWN.

    Description of Event or Problem · 1

    A PATIENT DEATH WAS REPORTED IN A PUBLICATION, C. PALMIERE ET AL., LEGAL MEDICINE (2015) FOR A PATIENT WHO UNDERWENT SI JOINT ARTHRODESIS IN (B)(6) 2013. PER THE CASE REPORT, HIS PAST MEDICAL HISTORY WAS SIGNIFICANT FOR LUMBAR DISCAL HERNIATION SURGERY, LUMBOSACRAL SPONDYLOLISTHESIS, LUMBAR LAMINECTOMY, VERTEBRAL FIXATION, SURGICAL REMOVAL OF FIXATION MATERIAL AND FORMER DRUG ADDICTION (COCAINE, ECSTASY, AMPHETAMINE). POSTMORTEM INVESTIGATIONS IDENTIFIED A PERFORATION OF A BRANCH OF THE RIGHT INTERNAL ILIAC ARTERY AND FOUND IT IS EXTREMELY LIKELY THAT THE PATIENT TOOK UNPRESCRIBED TRAMADOL. EVEN THOUGH HAIR ANALYSIS CONFIRMED UNPRESCRIBED TRAMADOL USE ON A REGULAR BASIS OVER THE MONTHS PRECEDING DEATH, THE UNPRESCRIBED TRAMADOL CONCENTRATION IN PERIPHERAL BLOOD WAS WITHIN TOXIC LEVELS AND WAS THEREFORE CONSIDERED CO-RESPONSIBLE FOR THE DEATH. THE OPERATING SURGEON IS CONTESTING THE FINDINGS OF THE REPORT AND THE PUBLICATION HAS BEEN WITHDRAWN. THE SURGEON AND HIS OPERATING ROOM TEAM, INCLUDING ANESTHESIOLOGISTS, DO NOT BELIEVE THE CAUSE WAS RELATED TO THE PROCEDURE AND DOES NOT ACCEPT THE PUBLISHED FINDINGS. AN INVESTIGATION IS CURRENTLY UNDERWAY AND THE SURGEON IS NOT PROVIDING ANY FURTHER INFORMATION UNTIL THE INVESTIGATION IS CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513131 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| H