BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2162128 · Received July 7, 2011

    Report

    Report Number
    2520274-2011-00505
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT IS PART OF AN IDE. PATIENT WITH PREVIOUS ATTEMPTED FUSION ANTERIORLY AT C6-C7, AND BILATERAL MASS SCREW AT C5 AND HOOK FIXATION AT C7 IS SUFFERING FROM SEVERE NECK PAIN AND HEADACHES REQUIRING POSTERIOR CERVICAL FUSION AT ADJACENT LEVEL C6-C7. MANUFACTURER OF THE HARDWARE HAS NOT BEEN POSITIVELY IDENTIFIED. THIS IS THE SECOND OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI HOOK KWP SYNTHES (USA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCREW