BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2946307 · Received February 6, 2013

    Report

    Report Number
    1030489-2013-00393
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    June 4, 2009
    Report Date
    January 10, 2013
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    NKB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: ROD INSERTION INSTRUMENT. (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT FACET JOINT ARTHRITIS L5-S1 AND DEGENERATIVE DISC DISEASE L5-S1. DURING INSERTION OF POSTERIOR FIXATION AT L5, THERE WAS DIFFICULTY REDUCING THE ROD ENOUGH TO INSERT THE SETSCREW. A MINI-OPEN INCISION WAS MADE ON THE RIGHT SIDE TO FORCE THE ROD DOWN INTO THE TULIP HEAD SO A SETSCREW COULD BE INSERTED. DURING INSERTION OF POSTERIOR FIXATION ON THE LEFT SIDE, THE GUIDE SYSTEM FOR THE L4 SCREW CAME LOOSE, SO ANOTHER MINI-INCISION WAS MADE TO INSERT THE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51355 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MSD BARTLETT MFG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Other