BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3140357 · Received May 31, 2013

    Report

    Report Number
    1030489-2013-02025
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE WITH HARDWARE IMPLANTATION. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT THE PATIENT SUFFERED SCIATIC PAIN AFTER MANUALLY LIFTING A HEAVY LOAD. WHEN THE PATIENT CAME IN FOR FOLLOW UP, IT WAS NOTED THAT SCREWS WERE BROKEN. COMPARISON WITH PREVIOUS CT SCAN IMPLIES THAT SCREWS WERE ALREADY BROKEN, BUT NOT NOTICED, AT THE EARLIER CT SCAN. PATIENT STATES PAIN IS ONGOING. PATIENT WAS GIVEN MEDICATION AND IS RECEIVING INJECTIONS. IF THE PAIN CANNOT BE MANAGED THIS WAY, A REVISION PROCEDURE WILL BE PERFORMED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241522 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention