BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PECTUS STABILIZER PLATE

    MDR report key: 220213 · Received April 23, 1999

    Report

    Report Number
    1032347-1999-00005
    Event Type
    Injury
    Date Received
    April 23, 1999
    Date of Event
    March 22, 1999
    Report Date
    April 22, 1999
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT REQUIRED REVISION SURGERY TO SECURE THE PECTUS STABILIZER PLATE WHICH BECAME DISASSOCIATED FROM THE BAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PECTUS STABILIZER PLATE Implant BONE PLATE FOR STABILIZATION OF PECTUS BAR HRS WALTER LORENZ SURGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention PECTUS SUPPORT BAR (8/27/1998 TO NA (CONTIN.)).