BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PECTUS BAR

    MDR report key: 1671197 · Received April 30, 2010

    Report

    Report Number
    1032347-2010-00056
    Event Type
    Injury
    Date Received
    April 30, 2010
    Report Date
    April 1, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K972420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. PRODUCT IS INTENDED TO AID TREATMENT OF PECTUS EXCAVATUM DEFORMITY.

    Description of Event or Problem · 1

    A RETROSPECTIVE REVIEW OF JOURNAL ARTICLES FROM 1999 TO 2010 WAS PERFORMED ON (B) (6), 2010. DURING REVIEW, DETERMINATION WAS MADE THAT DETAILS IN THE ARTICLE MAY NOT HAVE BEEN REPORTED FOR MEDWATCH FILING. ARTICLE: MINIMAL ACCESS TREATMENT OF PECTUS CARINATUM: A PRELIMINARY REPORT BY ANDRAS HOCK, IN THE PEDIATRIC SURG INT (2009) 25:337-342. THIS INITIAL EXPERIENCE REPORTS THE CORRECTION OF PECTUS EXCAVATUM USING A MINIMAL ACCESS TECHNIQUE IN FIVE MALE PATIENTS BETWEEN (B) (6) 2002 AND (B) (6) 2004. THERE WAS ONE DISLOCATION IN WHICH THE BAR WAS FINALLY REMOVED, AND IN THREE PATIENTS A PROLAPSE OF THE END OF THE STRUT THROUGH INTERCOSTAL SPACE NECESSITATED REFIXATION USING WIRES. IT WAS NOTED IN THE ARTICLE THE REASON FOR THE TECHNICAL FAILURE (FOR THE PATIENT REQUIRING BAR REMOVAL) OF THE PROCEDURE CAN BE ATTRIBUTED TO THE INCORRECT PATIENT SELECTION WITH AN ASYMMETRIC DEFORMITY AS THE ASYMMETRICAL PECTUS BAR PLACEMENT WAS RESPONSIBLE FOR THE UNSUCCESSFUL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PECTUS BAR PECTUS BAR HRS BIOMET MICROFIXATION

    Patients

    Seq Age Sex Outcome Treatment
    1