BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2862113 · Received December 7, 2012

    Report

    Report Number
    1030489-2012-02677
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K031655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: LATERAL VIEW OF LUMBAR SPINE WITH PEDICLE SCREW CONSTRUCT L3-5. ONE OF L5 SCREWS HAS BROKEN AND PEDICLE SLIGHT COLLAPSE HAS OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SCREW-ROD FIXATION SURGERY DUE TO AN ACCIDENT. APPROXIMATELY 20 MONTHS POST-OP IT WAS FOUND THAT THE SCREW WAS BROKEN. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE BROKEN SCREW. DUE TO THE LOCATION OF THE BROKEN SCREW, THE SCREW HEAD COULD NOT BE TAKEN OUT AND REMAINED IN THE PATIENT. THE OTHER PART OF THE BROKEN SCREW WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention RODS, SCREWS