BEUDAMED
    FDA Adverse Event Injury Summary report: N

    US SPINE

    MDR report key: 1548341 · Received November 24, 2009

    Report

    Report Number
    MW5013734
    Event Type
    Injury
    Date Received
    November 24, 2009
    Date of Event
    November 10, 2009
    Report Date
    November 24, 2009
    Manufacturer
    US SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD L4-S1 DECOMPRESSION, L4-5, L5-S1 POSTERIOR RADICAL DISCECTOMIES, L4-5, L5-S1 POSTERIOR INTERBODY FUSION - US SPINE 8MM AND 10 MM BANANA CAGES-, L4-S1 BILATERAL PEDICLE SCREW FIXATION -US SPINE-, L4-S1 BILATERAL LATERAL GUTTER FUSION. PT RETURNED IN 2009 FOR REMOVAL OF IMPLANTS, DUE TO BACK PAIN. UPON REMOVAL, ONE OF THE SET SCREWS WAS DISCOVERED TO BE BROKEN IN HALF. DATES OF USE: 2008 - 2009. DIAGNOSIS OR REASON FOR USE: DEGENERATIVE LUMBAR DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 US SPINE SET SCREW KWQ US SPINE USST101791

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability