BEUDAMED
    FDA Adverse Event Other Summary report: N

    VSP SPINAL SYSTEM

    MDR report key: 378275 · Received February 21, 2002

    Report

    Report Number
    1526439-2002-00008
    Event Type
    Other
    Date Received
    February 21, 2002
    Date of Event
    January 1, 2002
    Report Date
    February 21, 2002
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT A VSP SCREW BROKE POST-OPERATIVELY. THE SCREW WAS IMPLANTED IN 2001 AND WAS EXPLANTED IN 2002. THE SCREW WAS RETURNED AND IS CURRENTLY BEING EVALUATED. NO FURTHER ACTION CAN BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSP SPINAL SYSTEM PEDICLE SCREW MCV DEPUY ACROMED, INC. NA U1484

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other