BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3052037 · Received April 11, 2013

    Report

    Report Number
    1030489-2013-00991
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    February 10, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PEDICLE SCREWS WERE IMPLANTED IN 1992 (YEAR VALID). PEDICLE SCREWS WERE EXPLANTED IN 1997(YEAR VALID) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE IN WHICH PEDICLE SCREWS WERE IMPLANTED. SOMETIME POST OPERATIVELY FOR UNSPECIFIED REASONS, THEY HAD TO BE REMOVED. PATIENT CLAIMS THEY WRECKED HIS LIFE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    LEVELS: L5-S1 DURING PATIENT CALL IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT COMPLAINED THAT "PAIN RUNNING DOWN BOTH LEGS PRIMARILY LEFT LEG (NUMB AREAS). HAS SATTLE ANESTHESIA. SOME DAYS CAN'T WALK, OTHERS CAN WALK WITH STRUGGLE, NO STRENGTH. ATTEMPTS AT ACTIVITY CAUSES SO MUCH PAIN IT PUTS HIM IN BED. NO SEX DRIVE". THE PATIENT WAS ON SWIMMING POOL THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT STATED THAT "IN 1997 A CT SCAN SHOWED A SCREW WAS TOUCHING A NERVE AND THE SCREW AND ALL HARDWARE WERE REMOVED IN 1997. PATIENT'S CURRENT STATUS IS "DEPRESSED," AND HAS A LOT OF STRESS AND NO CONTROL ON BOWELS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS IN CONSTANT PAIN AND DISABLED NOW. THE PATIENT IS UNABLE TO MOW HIS OWN YARD. THE PATIENT ALSO HAD NERVE DAMAGE IN LEG AND ISSUE LIKE POOPING 10-12 TIMES A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154430 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention