BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENOR SPINAL SYSTEM

    MDR report key: 1210748 · Received October 23, 2008

    Report

    Report Number
    1030489-2008-00593
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 24, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MEDTRONIC AND EVALUATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SELF BREAKING NUT WOULD NOT BREAK OFF AND ANOTHER INSTRUMENT WAS USED TO CUT THE SELF BREAKING NUT. TWO WEEKS POST-OP, THE PATIENT UNDERWENT A REVISION SURGERY, DUE TO A REPOSITIONING OF THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENOR SPINAL SYSTEM SELF BREAKING NUT KWP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention