BEUDAMED
    FDA Adverse Event Other Summary report: N

    LACTOSORB PECTUS STABILIZER

    MDR report key: 2555917 · Received March 4, 2009

    Report

    Report Number
    1032347-2009-00023
    Event Type
    Other
    Date Received
    March 4, 2009
    Date of Event
    February 2, 2009
    Report Date
    February 13, 2009
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    HRS
    PMA / PMN Number
    K071577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF PHOTO TAKEN BY DOCTOR'S OFFICE. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD PECTUS SUPPORT BAR AND LACTOSORB PECTUS STABILIZER IMPLANTED (B)(6) 2008. DURING A F/U VISIT ON (B)(6) 2009 THE PT HAS NOTICED MORE TENDERNESS AT THE RIGHT INCISION SITE AT THE LOCATION OF THE STABILIZER. SURGICAL SITE IS POINTING AND SLIGHTLY DISCOLORED PURPLISH. WITH GENTLE PALPATION, SKIN OPENED AND WHITISH MATERIAL IS VISIBLE EXTENDING THROUGH SKIN. MINIMAL TENDERNESS. PT WAS ADMINISTERED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB PECTUS STABILIZER RESORBABLE PLATE HRS BIOMET MICROFIXATION, INC. 779620

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization