BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1834484 · Received September 10, 2010

    Report

    Report Number
    1030489-2010-01165
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MFG
    Product Code
    KWQ
    PMA / PMN Number
    K091974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW CROSS THREADED, SHEARED AND SOME SHAVINGS WAS OFF THE SET SCREW DURING INSERTION. THE SET SCREW WAS REMOVED AND REPLACED. NO SHAVINGS LEFT IN THE PT. NO PT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| PEDICLE SCREW: