BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3193050 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02589
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 # 7751728, #6950315, #7751724, #7751714, #7751716, #7752537, #7750088, #7751101. (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT STATED THAT THERE IS NO ALLERGY TO THE HARDWARE.

    Description of Event or Problem · 1

    PATIENT CONTACTED MEDTRONIC AND REPORTED THAT SHE HAD GRAFTON PUTTY IMPLANTED DURING A POSTERIOR CERVICAL FUSION ON (B)(6) 2011, AND SHE HAS SINCE FOUND OUT THAT IT MAY HAVE BEEN RECALLED. PATIENT WAS ¿WONDERING IF THIS WAS THE CASE¿ BECAUSE, ACCORDING TO HER, SHE IS HAVING ¿ALL KINDS OF TROUBLE¿ (BONE OVERGROWTH, ETC.) PATIENT LEFT HER TELEPHONE NUMBER. PATIENT WAS CONTACTED BY MEDTRONIC PATIENT LIAISON. PATIENT STATED THAT, BEGINNING 6 WEEKS AFTER HER SURGERY SHE HAS HAD A RASH AND ¿LUMP¿ IN THE BACK OF HER NECK DIRECTLY OVER THE INSTRUMENTATION. PATIENT STATED SHE HAS HAD NUMEROUS X-RAYS AND CT SCANS, AND DOCTORS WILL NOT CONFIRM IF SHE HAS FUSED AND SHE IS FRUSTRATED. SHE STATED SHE HAD HEARD THE GRAFTON PUTTY MAY HAVE BEEN INVOLVED IN A RECALL, AND PATIENT LIAISON EXPLAINED THE DETAILS OF THE RECALL TO THE PATIENT, INDICATING THAT IT INVOLVED THE POTENTIAL FOR INFECTION, WHICH THE PATIENT STATED SHE HAS NOT HAD. PATIENT DID NOT HAVE ANY DETAILS ON HER SURGERY (LOT INFORMATION OF GRAFT AND/OR HARDWARE, DATES, ETC.), HOWEVER, AND WAS ASKED TO OBTAIN THE IMPLANT LOG FROM HER PROCEDURE TO CONFIRM IF GRAFTON WAS IN FACT PART OF THE RECALL VIA LOT INFORMATION. UPDATED INFORMATION (B)(6) 2013: PATIENT OBTAINED AND PROVIDED THE IMPLANT LOG FROM HER SURGERY TO MEDTRONIC'S PATIENT LIAISON. THE INSTRUMENTATION USED IN THE PROCEDURE WAS CONFIRMED TO BE MEDTRONIC PRODUCT AS WELL. IN THE EMAIL IN WHICH SHE SENT THE LOG, THE PATIENT STATED: "WE SPOKE LAST WEEK REGARDING THE POSSIBILITY THAT THE HARDWARE USED IN MY CERVICAL SPINE C1, C2 FUSION SURGERY IN (B)(6) 2011, MAY BE THE CAUSE OF THE RASH (POSSIBLE ALLERGIC REACTION) DIRECTLY OVER THE HARDWARE SITE. AS YOU REQUESTED, I HAVE ATTACHED THE IMPLANT LOG. I HOPE THAT THIS INFORMATION WILL HELP YOU DETERMINE WHICH METALS WERE USED. MY DERMATOLOGIST NEEDS THIS INFORMATION FOR ALLERGY PATCH TESTING. IF YOU CAN GET BACK TO ME AT YOUR EARLIEST CONVENIENCE, I WOULD GREATLY APPRECIATE IT." THE PATIENT REPORTEDLY IS FOLLOWING-UP WITH AN ALLERGIST AND REQUESTED THE METAL COMPOSITION FROM HER DEVICES. THIS INFORMATION WAS PROVIDED BY COMPLAINTS PERSONNEL TO MEDTRONIC'S PATIENT LIAISON. THE IMPLANT LOG IS ATTACHED TO THIS RECORD. THE LOT OF GRAFTON PUTTY LISTED ON THE IMPLANT LOG WAS CONFIRMED TO HAVE BEEN AMONG THOSE VOLUNTARILY RECALLED BY MEDTRONIC IN APRIL, 2012. DUE TO A POTENTIAL PACKAGING ISSUE WHICH COULD HAVE POTENTIALLY RESULTED IN INFECTION. THE PATIENT REPORTED THAT SHE HAD NEVER DEVELOPED ANY INFECTION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292709 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RODS, SCREWS, TISSUE