BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9024543 · Received September 13, 2019

    Report

    Report Number
    1030489-2019-01019
    Event Type
    Injury
    Date Received
    September 13, 2019
    Report Date
    September 13, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    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 # 55811016045, 510K # K122433 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 THE PATIENT UNDERWENT POSTEROLATERAL SPINAL FUSION AT T12-L2 TO TREAT BURST FRACTURE AT L1. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW BROKE. KYPHOSIS WAS ALSO OBSERVED. HENCE, A REVISION SURGERY WAS PERFORMED DUE TO SCREW BREAKAGE. IN THIS SURGERY, LAMINA HOOK WAS PLACED AT L2, AND FIXATION WAS PERFORMED AGAIN. FURTHERMORE, X-CORE WAS PERFORMED AT L1 FROM THE ANTERIOR SIDE. AS THE BREAKAGE OCCURRED AT THE BASE OF THE SCREW SHAFT, THE SCREW HEAD WAS EXPLANTED WHEREAS THE THREADED SHAFT REMAINED IMPLANTED IN THE BONE. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817695 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention