BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMPLICITY

    MDR report key: 2583928 · Received May 16, 2012

    Report

    Report Number
    MW5025452
    Event Type
    Injury
    Date Received
    May 16, 2012
    Date of Event
    June 3, 2011
    Report Date
    May 16, 2012
    Manufacturer
    SPINAL USA
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 2 LEVEL ACDF SURGERY AT C4-5 AND C5-6 PLANNED. SURGEON OPERATED AT THE WRONG LEVEL. SURGEON DID NOT NOTICE MIS-LABELED LEVELS ON X-RAY FILMS, INADVERTENTLY REMOVED/FUSED THE C3-C4 LEVEL. THE DECISION WAS THEN MADE TO PROCEED WITH THE C5-C6 DISCECTOMY. AFTER REALIZATION, THE TWO-LEVEL PLATE COVERING THE C3-C5 VERTEBRA WAS REMOVED. LEVEL C5-6 WAS DONE AND A 3 LEVEL VERTEBRAL PLATE WAS OBTAINED AND APPLIED OVER THE THREE SEGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM KWQ SPINAL USA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| S SPINAL USA