BEUDAMED
    FDA Adverse Event Other Summary report: N

    VSP SPINAL SYSTEM

    MDR report key: 378283 · Received February 21, 2002

    Report

    Report Number
    1526439-2002-00010
    Event Type
    Other
    Date Received
    February 21, 2002
    Date of Event
    September 1, 2001
    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. THE SCREW HAS NOT BEEN EXPLANTED. THE LOT NUMBER WAS NOT REPORTED BY THE COMPLAINTANT. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other