BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 450360 · Received March 27, 2003

    Report

    Report Number
    1526439-2003-00022
    Event Type
    Other
    Date Received
    March 27, 2003
    Report Date
    March 27, 2003
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    KWQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A SPINAL IMPLANT WAS INVOLVED IN A PRODUCT LIABILITY LAW SUIT. THE PART AND LOT NUMBERS WERE NOT REPORTED AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER EVALUATION CAN BE PERFORMED. IT CANNOT BE VERIFIED THAT THE PRODUCT IN QUESTION IS A DEPUY ACROMED PRODUCT. NO FURTHER ACTION CAN BE TAKEN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other