BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 372715 · Received January 21, 2002

    Report

    Report Number
    1526439-2002-00005
    Event Type
    Other
    Date Received
    January 21, 2002
    Report Date
    January 21, 2001
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEPUY ACROMED RECEIVED A MEDWATCH FORM FROM THE FDA. ALL CONTACT INFORMATION IS REDACTED ON THE FORM. THE COMPLAINANT STATED THAT THE PATIENT WAS IMPLANTED WITH PEDICLE SCREWS AND SHORTLY AFTER THEY BROKE. THE PATIENT HAD A REVISION SURGERY BUT THERE HAS BEEN NO SIGNIFICANT IMPROVEMENT IN THE PATIENT'S PAIN LEVEL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other