BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8140920 · Received December 7, 2018

    Report

    Report Number
    1030489-2018-01612
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 7, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    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 SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 1476200500 AND 510K# K132111 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE US. 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

    TYPE OF PROCEDURE: FIXATION WAS PERFORMED AT T9-S2 WITH S4. IT WAS REPORTED THAT ON (B)(6) 2018, POST-OP, THE ROD WAS FOUND TO BE BROKEN NEAR L1. HENCE, ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN ROD WAS CONNECTED WITH 4 CONNECTORS (IN TOTAL) ON THE LEFT AND RIGHT SIDE. THEN, A NEW ROD WAS INSERTED FOR REINFORCEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981940 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention