BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE WAVE

    MDR report key: 6633138 · Received June 8, 2017

    Report

    Report Number
    MW5070292
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    March 2, 2017
    Report Date
    May 30, 2017
    Manufacturer
    SPINE WAVE
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, SURGERY; L4-L5 AND L5-S1 TRANSFORAMINAL DECOMPRESSION. LEFT L4-L5 AND L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (LAVA CAGE, AUTOGRAFT, NOVABONE. RIGHT L4-L5 AND L5-S1 POSTEROLATERAL ON LAY FUSION (AUTOGRAFT, NOVABONE). BILATERAL L4-L5 AND L5-S1 PEDICAL SCREW FIXATION USING SPINEWAVE SNIPER PERCUTANEOUS SYSTEM. ON (B)(6) 2017 POST-OP VISIT; LS X-RAYS DETERMINED COLLAPSE OF THE TITANIUM GRAFT AT L5-S1 WHICH HAD CHANGED COMPARED TO PREVIOUS STUDIES. PT SCHEDULED FOR SURGICAL INTERVENTION WITH REMOVAL OF PREVIOUS INTERBODY CAGE. ON (B)(6) 2017 SURGERY; L5-S1 ANTERIOR LUMBAR INTERBODY FUSION AND PLATING (PEEK), REMOVAL INTERBODY CAGE (SPINE WAVE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401888 SPINE WAVE LEVA CAGE SPACER SYSTEM MAX SPINE WAVE 661P257.14

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention