BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7033913 · Received November 15, 2017

    Report

    Report Number
    1030489-2017-02335
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 19, 2017
    Report Date
    November 15, 2017
    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 USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5442147 510K # K091974 AND UPN (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.

    Description of Event or Problem · 1

    PROCEDURE:POSTERIOR LUMBAR INTERBODY FUSION IT WAS REPORTED THAT PATIENT UNDERWENT AN UNSPECIFIED SURGERY AND IMPLANTS WERE PLACED AT L1/2 AND L5/S1. POST-OP, THE HEX PART OF THE CROSSLINK PROTRUDED AND PATIENT DEVELOPED PAIN AND DECUBITUS. PATIENT UNDERWENT REVISION FOR REMOVAL OF THE CROSSLINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811689 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R