BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS COMPRESSION STAPLE

    MDR report key: 5104404 · Received September 23, 2015

    Report

    Report Number
    3010673777-2015-00001
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    January 27, 2015
    Report Date
    September 1, 2015
    Manufacturer
    NOVASTEP
    Product Code
    JDR
    PMA / PMN Number
    K142111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO EXTREMITY MEDICAL IN (B)(6) THAT THE PATIENT'S BONE FRACTURED WHILE THE SURGEON WAS TEMPING IN THE STAPLE (BASE WEDGE OSTEOTOMY). THE SURGEON NOTED THAT THE PATIENT HAD POOR BONE QUALITY AND THIS LED TO THE FRACTURE. THERE WAS NOT A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629406 EXPRESS COMPRESSION STAPLE COMPRESSION STAPLE JDR NOVASTEP 139-15-1414-S 140015

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention