BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    MDR report key: 3923865 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03190
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). UNKNOWN PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TWO LEVEL LUMBAR FUSION AT L4/5 AND L5/S1. SOMETIME POST-OP THE PATIENT REPORTED HAVING "A LOT OF NERVE PROBLEMS AND SWELLING" AND REQUIRED ANOTHER FUSION PROCEDURE TO BE PERFORMED AT S1 . NO FURTHER INFORMATION COULD BE OBTAINED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401128 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention DISCS, RODS, SCREWS, PLATES