BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3012717 · Received March 20, 2013

    Report

    Report Number
    1030489-2013-00788
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE AT THORACIC 9-L2, THORACIC 9(HOOK)-THORACIC 10,THORACIC 11(PEDICLE SCREWS)-LUMBAR 1, LUMBAR 2(PEDICLE SCREWS), AND A CORPECTOMY AT THORACIC 12. IT WAS REPORTED DURING COMPRESSION ON SCREW-ROD CONSTRUCT AT THORACIC 11 THAT THE PEDICLE FRACTURED. THE FRACTURE CAUSED THORACIC 11 SCREW LOOSENING. THE SCREW WAS REMOVED AND THE SURGEON USED A COMPETITOR'S CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115680 UNKNOWN NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Other