BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ PECTUS SUPPORT BAR

    MDR report key: 224054 · Received May 17, 1999

    Report

    Report Number
    1032347-1999-00012
    Event Type
    Injury
    Date Received
    May 17, 1999
    Date of Event
    April 8, 1999
    Report Date
    May 14, 1999
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Product Code
    HRS
    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

    ON 1/19/1999, THE PT UNDERWENT SURGICAL PROCEDURE, IMPLANTING TWO PECTUS SUPPORT BARS AND STABILIZERS FOR CORRECTION OF STERNAL DEFORMITY. ON 4/8/1999 REVISION PROCEDURE WAS PERFORMED TO REPOSITION AND STABILIZE A BAR THAT HAD SLIPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention PECTUS STABILIZER PLATE (FROM 1/19/1999).