BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEFLEX 4.5MM DISCECTOMY SYSTEM

    MDR report key: 2264252 · Received August 26, 2011

    Report

    Report Number
    3007209822-2011-00001
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 26, 2011
    Manufacturer
    LAURIMED LLC
    Product Code
    HRX
    PMA / PMN Number
    K090815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USER HANDLING. MFR'S DEVICE EVAL SUMMARY: THE DEVICE AND FRAGMENT WERE INSPECTED UNDER THE MICROSCOPE. IT WAS CONFIRMED THAT THE ENTIRE FRAGMENT WAS RETRIEVED. INSPECTION OF THE FRAGMENT REVEALED EVIDENCE OF DISLODGEMENT BY A COMPRESSIVE FORCE FOLLOWED BY A TENSILE FORCE ON THE PEBAX SHAFT. A VIDEO PROVIDED BY THE PHYSICIAN WAS REVIEWED. IT SHOWED THE DISCECTOMY DEVICE WORKING PROPERLY IN THE ANNULOTOMY ON THE PT'S RIGHT SIDE EARLY IN THE SURGERY. RESECTED TISSUE WAS EVIDENT IN THE FILTER CHAMBER. SUBSEQUENTLY, THE VIDEO SHOWED THAT THE SURGEON HAD DIFFICULTY INSERTING THE DEVICE INTO THE ANNULOTOMY ON THE PT'S LEFT SIDE. SEVERAL ATTEMPTS WERE MADE TO INCREASE THE SIZE OF THE ANNULOTOMY TO ALLOW PASSAGE OF THE DEVICE PROVE INTO THE INTRADISCAL SPACE. AT THE TIME THE DEVICE FAILED, THE VIDEO SHOWED THE CANNULA WAS POSITIONED ON OR NEAR THE ANNULOTOMY AND THE DEVICE WAS FORCIBLY PUSHED IN AN ATTEMPT TO ACCESS THE INTRADISCAL SPACE. THE DEVICE WAS WITHDRAWN FROM THE SITE AND INSPECTION REVEALED THE DISTAL TIP OF THE PROBE WAS MISSING. THE MISSING TIP WAS SUBSEQUENTLY RETRIEVED FROM THE INTRADISCAL SPACE. THE FAILURE WAS RECREATED BY LAURIMED ENGINEERS ON A BENCHTOP MODEL USING AN UNUSED 4.5 MM DISCECTOMY DEVICE. THE TEST WAS SET UP TO MIMIC THE COMPRESSIVE AND TENSILE FORCES THE DEVICE WAS EXPOSED TO DURING THE PROCEDURE. THE COMPLAINT WAS CONFIRMED AND REPLICATED.

    Description of Event or Problem · 1

    A BILATERAL TLIF WAS PERFORMED USING THE DISCECTOMY DEVICE. SUBSEQUENT TO THE SECOND OR THIRD USE ON THE SECOND SIDE ACCESSED, UPON REMOVAL OF THE DEVICE, IT WAS NOTICED THAT THE PLASTIC SHEATH OVER THE TIP WAS MISSING. THE PLASTIC WAS SEEN ON THE X-RAY IN THE DISC SPACE AND THEN REMOVED WITH A PITUITARY. THEREAFTER THE BILATERAL TLIF INCLUDING CAGE PLACEMENT AND GRAFTING WAS REPORTED TO HAVE BEEN PERFORMED UNEVENTFULLY WITH NO PT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDEFLEX 4.5MM DISCECTOMY SYSTEM HRX LAURIMED LLC FG-000008 LFG 060210-2

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR