BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSTAPLE

    MDR report key: 2148835 · Received June 24, 2011

    Report

    Report Number
    1649263-2011-00001
    Event Type
    Injury
    Date Received
    June 24, 2011
    Date of Event
    June 2, 2009
    Report Date
    June 23, 2011
    Manufacturer
    BIOMEDICAL ENTERPRISES, INC.
    Product Code
    JDR
    PMA / PMN Number
    K993714
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAS FILED SUIT IN (B)(6). MANUFACTURER IS CURRENTLY UNAWARE OF ANY DETAILS CONCERNING THE CASE.

    Description of Event or Problem · 1

    ON (B)(6), 2009, PATIENT HAD OSTEOTOMIES PERFORMED BILATERALLY ON FIRST METATARSALS WHERE AN OSSTAPLE WAS USED. AFTER SURGERY, THE PATIENT'S LEFT OSTEOTOMY BECAME DISPLACED. ON (B)(6), 2009, PATIENT UNDERWENT SURGERY TO REMOVE OSSTAPLE AND/OR OTHER HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSSTAPLE JDR BONE STAPLE JDR BIOMEDICAL ENTERPRISES, INC. 0907W1.5 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention