BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2111660 · Received June 2, 2011

    Report

    Report Number
    1030489-2011-00654
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K031655
    Removal / Correction Number
    1030489-060211-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MISLABELED. THE SCREW WAS RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE SCREW WAS INCORRECTLY ETCHED. THE SCREW MEASURED 5.0 X 35 AND WAS LASER MARKED 5.0 X 30. 1030489-060211-001-R.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ETCHING ON THE PART DID NOT MATCH THE PACKAGED. THE DEVICE WAS FOUND OUTSIDE OF SURGERY AND WAS NOT USED TO TREAT A 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 H10B4589

    Patients

    Seq Age Sex Outcome Treatment
    1