BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ PECTUS SUPPORT BAR

    MDR report key: 228814 · Received June 22, 1999

    Report

    Report Number
    1032347-1999-00013
    Event Type
    Injury
    Date Received
    June 22, 1999
    Date of Event
    May 17, 1999
    Report Date
    June 21, 1999
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Product Code
    IME
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 1998, THE PATIENT UNDERWENT SURGERY TO CORRECT STERNAL DEFORMITY. TWO PECTUS SUPPORT BARS AND STABILIZERS WERE IMPLANTED. WHILE SWINGING A GOLF CLUB, ON BAR BECAME DISLODGED, REQUIRING REVISION. THE REVISION SURGERY WAS PERFORMED IN 99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORENZ PECTUS SUPPORT BAR Implant RETROSTERNAL STRUT IME WALTER LORENZ SURGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention PECTUS STABILIZER PLATE (11/24/1998 TO NA).