BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPRO MEMORY STAPLE

    MDR report key: 1001481 · Received February 20, 2008

    Report

    Report Number
    1833506-2008-00001
    Event Type
    Other
    Date Received
    February 20, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 19, 2008
    Manufacturer
    BIOPRO, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STAPLE WAS REC'D AND INSPECTED. STAPLE COMPRESSED AT TEMPERATURE EXPECTED. REVIEW OF PT X-RAYS LOOKED GOOD. NO DEFECTS FOUND. NO ABNORMALITIES FOUND THAT WOULD INDICATE FAILURE OF DEVICE.

    Description of Event or Problem · 1

    AFTER PT HEALED (APPROX 6-8 WEEKS POST-OP) STAPLE BACKED OUT OF BONE AND BECAME PAINFUL. STAPLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO MEMORY STAPLE STAPLE GDW BIOPRO, INC. 17627 105963

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention