BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDTRONIC HARDWARE

    MDR report key: 2833417 · Received November 15, 2012

    Report

    Report Number
    1030489-2012-02206
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WITH THE AVAILABLE INFORMATION WE ARE UNABLE TO DETERMINE A CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT SURGERY FOR TREATMENT OF INTRACTABLE NECK PAIN AND A REPEAT CERVICAL FUSION. IT IS ALLEGED THAT AFTER SURGERY, THE PATIENT BEGAN TO EXPERIENCE INTRACTABLE NECK PAIN AND DIFFICULTY SWALLOWING. SUBSEQUENTLY THE PATIENT WAS INFORMED THAT THE PLATE HAD MOVED AND AS A RESULT HAD PROTRUDED INTO ADJACENT TISSUE. IT IS REPORTED THAT BECAUSE OF THIS MIGRATION, THE PATIENT ALLEGEDLY SUFFERS AND WILL CONTINUE TO SUFFER NECK PAIN AND DYSPHAGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MEDTRONIC HARDWARE APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other