BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE

    MDR report key: 3032834 · Received February 22, 2013

    Report

    Report Number
    3005670412-2013-00003
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ACUTE INNOVATIONS
    Product Code
    HRS
    PMA / PMN Number
    K120163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SALES REPRESENTATIVE INTERVIEWED. SURGEON REPORTED THAT PATIENT WAS NOT COMPLAINT WITH POST-OP ACTIVITY RESTRICTIONS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A PECTUS EXCAVATUM CORRECTION. PLATES WERE USED AS ADDITIONAL STABILIZATION OF THE CORRECTED STERNUM. APPROXIMATELY 6-7 WEEKS POST-OP THE PATIENT REPORTED HEARING A CRACKING SOUND WHEN SHE ROLLED ONTO HER SIDE IN BED. THE NEXT MORNING WHILE LIFTING HER CHILD SHE FELT SOMETHING GIVE WAY IN HER CHEST. A SECOND SURGERY WAS PERFORMED. THE SURGEON NOTED THAT THE LOWER PLATE CONSTRUCT HAD BROKEN ALONG THE STERNUM. THE SURGEON REMOVED THE BROKEN SEGMENT AND RE-PLATED THE SEGMENT WITH A NEW PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79245 BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE BIOBRIDGE PLATE HRS ACUTE INNOVATIONS RRP1501 L1108007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention