BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE

    MDR report key: 4170548 · Received July 11, 2014

    Report

    Report Number
    3005670412-2014-00001
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 7, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ACUTE INNOVATIONS LLC
    Product Code
    HRS
    PMA / PMN Number
    K120163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BIOBRIDGE PLATE WAS INSTALLED FOLLOWING A CHEST WALL TUMOR RESECTION. THE PT WAS RE-OPERATED ON 5 DAYS LATER TO REMOVE ADDITIONAL NEOPLASTIC TISSUE. DURING THE SECOND SURGERY THE BIOBRIDGE PLATE WAS FOUND TO BE BROKEN AND WAS REMOVED. THE CAUSE OF THE PLATE BREAKAGE COULD NOT BE DETERMINED SINCE THE PLATE WAS NOT RETURNED TO THE MFR. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION AND THERE WAS NO ALLEGATION OF PT HARM DUE TO THE BROKEN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408423 BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE BIOBRIDGE PLATE HRS ACUTE INNOVATIONS LLC RRP1501 L1303007

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention