BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9760849 · Received February 27, 2020

    Report

    Report Number
    1030489-2020-00226
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Report Date
    February 27, 2020
    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

    OTHER: PAIN. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440030, 510K # K102555, 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 PATIENT UNDERWENT UNKNOWN SURGERY BECAUSE BACK PAIN DUE THE OCCURRENCE OF THORACIC PJK AND LOWER BACK PAIN DUE TO THE FAILURE OF L5/S1 BONE UNION. POST-OP, AFTER THE FIXATION AT TH10/S2AI, SET SCREW AT BOTH SIDES OF S2AI BACKED OUT. THE PATIENT SUFFERED BACK PAIN DUE THE OCCURRENCE OF THORACIC PJK. BONE UNION OF L5/S HAD NOT BEEN ACHIEVED. HENCE A REVISION SURGERY WILL SCHEDULE ON (B)(6) 2020 (IT IS UNKNOWN WHETHER THE REVISION SURGERY WERE PERFORMED OR NOT), IN WHICH PARTIAL SCREW REMOVAL AND THE REPLACEMENT OF SET SCREW WILL BE PERFORMED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. NO OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226546 CD HORIZON SPINAL SYSTEM KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R