BEUDAMED
    FDA Adverse Event Other Summary report: N

    VSP SPINAL SYSTEM

    MDR report key: 374083 · Received January 25, 2002

    Report

    Report Number
    1526439-2002-00006
    Event Type
    Other
    Date Received
    January 25, 2002
    Date of Event
    December 1, 2001
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT A VSP PEDICLE SCREW BROKE POST-OPERATIVELY. IT WAS INITIALLY IMPLANTED IN 2001. THE SCREW WAS EXPLANTED 5 MONTHS LATER. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSP SPINAL SYSTEM PEDICLE SCREW MCV DEPUY ACROMED, INC. NA 0944W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other