BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 2988006 · Received March 4, 2013

    Report

    Report Number
    1030489-2013-00663
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840005530, 510K # K091974 WAS CLEARED IN THE UNITED STATES. (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVELS L2-L3 AND L4-L5, THE LAMINA CRACKED. THE SURGEON WAS ABLE TO PLACE A SCREW AT THE LAMINA WITHOUT ANY PROBLEMS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91752 CD HORIZON® SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1