BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7888652 · Received September 19, 2018

    Report

    Report Number
    1030489-2018-01263
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    August 21, 2018
    Report Date
    September 19, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    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 # 75445545, 510K #K031655 AND UDI # (B)(4) 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNWON DATE, POST-OP, THE IMPLANTED SCREWS WERE LOOSENED. A REVISION SURGERY WAS PERFORMED AND THE SCREWS WERE REPLACED. ALSO, RE-FIXATION AND RE-CORRECTION WAS DONE. PROXIMAL JUNCTIONAL KYPHOSIS(PJK) HAS BEEN REPORTED AS PATIENT COMPLICATIONS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731716 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H11L3485

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R