BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1854147 · Received September 3, 2010

    Report

    Report Number
    1030489-2010-01126
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SET SCREWS WERE NOT RETURNED TO THE MANUFACTURE FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TLIF USING POSTERIOR FIXATION AT L5-S1. THE SET SCREW KEPT SHREDDING ON INSERTION INTO THE PEDICLE SCREW. THE PEDICLE SCREW WAS REPLACED AND NEW SET SCREW WAS IMPLANTED WITHOUT FURTHER INCIDENT. IT WAS FOUND THAT THE REMOVED PEDICLE SCREW HEAD WAS ALSO DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW NKB MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR PEDICLE SCREW NOT IMPLANTED.