BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6394162 · Received March 10, 2017

    Report

    Report Number
    1030489-2017-00500
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 13, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840016540, 510K # K091974 WAS CLEARED IN THE UNITED STATES. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: SPINAL KYPHOSIS PROCEDURE: VERTEBRAL BODY REPLACEMENT AND POSTERIOR LUMBAR FUSION IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE PATIENT COMPLAINED OF LOWER LIMBS PAIN. THE LOWER LIMBS PAIN TENDS TO BE REDUCED WHEN THE PATIENT STRETCHES HER JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178712 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H13T1211

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other