BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2111606 · Received June 2, 2011

    Report

    Report Number
    1030489-2011-00653
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    July 19, 2010
    Report Date
    June 2, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Removal / Correction Number
    1030489-060211-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MISLABELED. 1030489-060211-001-R. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER ADDITIONAL PRODUCT FROM THE SAME LOT WERE INSPECTED AND WERE FOUND TO BE OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE ETCHING ON THE PART DID NOT MATCH THE PACKAGING. THE SURGEON MEASURED THE SCREW AND CONFIRMED IT TO BE THE APPROPRIATE SIZE. THE SCREW WAS IMPLANTED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H09M9774

    Patients

    Seq Age Sex Outcome Treatment
    1 ROD, SET SCREW