BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 376875 · Received February 19, 2002

    Report

    Report Number
    1526439-2002-00007
    Event Type
    Other
    Date Received
    February 19, 2002
    Report Date
    February 19, 2001
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DEPUY ACROMED RECEIVED A MEDWATCH FORM FROM THE FDA AND INFORMATION WAS REDACTED FROM THE FORM. THE PRODUCT AND LOT CODES WERE NOT REPORTED. ACCORDING TO THE COMPLAINANT, THE TIPS OF THE PEDICLE SCREWS WERE NOT REMOVED WITH THE WRENCH DURING THE INITIAL SURGERY AND A SECOND PROCEDURE WAS REQUIRED. THE PRODUCT AND LOT CODES WERE NOT REPORTED. THE SCREWS WERE NOT RETURNED FOR EVALUATION. NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICES ARE DEPUY ACROMED PRODUCTS.

    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