BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ PECTUS SUPPORT BAR

    MDR report key: 222194 · Received May 7, 1999

    Report

    Report Number
    1032347-1999-00010
    Event Type
    Injury
    Date Received
    May 7, 1999
    Report Date
    May 6, 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

    THE PT REQUIRED REVISION SURGERY TO REPOSITION AND STABILIZE A PECTUS SUPPORT BAR THAT BECAME DISPLACED. THE BAR WAS ORIGINALLY IMPLANTED 7/23/98 TO REPAIR STERNAL DEFORMITY.

    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 12 YR Required Intervention PECTUS SUPPORT BAR STABILIZER (8/12/98 TO UNK)