BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3820559 · Received May 20, 2014

    Report

    Report Number
    1030489-2014-02579
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE: CATALOG # 7540120, LOT # UNKNOWN, EXPIRATION DATE N/A. CATALOG # 8690030, LOT # UNKNOWN, EXPIRATION DATE N/A. CATALOG # 8690040, LOT # UNKNOWN, EXPIRATION DATE N/A. CATALOG # 9393008, LOT # H11B6426, EXPIRATION DATE 12/22/2019. CATALOG # 75446535, LOT # UNKNOWN, EXPIRATION DATE N/A. CATALOG # 75446540, LOT # UNKNOWN, EXPIRATION DATE N/A. CATALOG # A43105, LOT # UNKNOWN, EXPIRATION DATE N/A. CATALOG # 7510200, LOT # M111101AAQ, EXPIRATION DATE 08/01/2014. MANUFACTURE DATE FOR CATALOG # 9393008, LOT # H11B6426 IS 12/23/2011; MANUFACTURE DATE FOR CATALOG # 7510200, LOT # M111101AAQ IS 02/02/2012.

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 7540120, # 8690030 AND # 8690040. (B)(4). GMA/510K#: 7540120, 510K K052187; 8690030, 8690040, 510K K010181. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. 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 THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. APPROXIMATELY 10 MONTHS POST-OP, THE PATIENT UNDERWENT A REVISION SURGERY FOLLOWING A MOTOR VEHICLE ACCIDENT. IT WAS REPORTED THAT SOMETIME POST-OP THE PATIENT DEVELOPED AN AUTO-IMMUNE DISEASE AND MAY ALSO BE HAVING AN ALLERGIC REACTION. THE PATIENT IS SEEING AN ALLERGIST TO FIND OUT WHAT IS CAUSING THE ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298796 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCREWS, RODS, VB REPLACEMENT