BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    MDR report key: 3133064 · Received May 29, 2013

    Report

    Report Number
    1030489-2013-01916
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A CERVICAL PLATE IMPLANT BEGAN EXPERIENCING "ALLERGIC REACTIONS, FATIGUE, VERTIGO, RASH" APPROXIMATELY ONE MONTH POST-OP. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235981 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other