BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEOPARD 9MM VBR IMPLANT

    MDR report key: 494259 · Received November 7, 2003

    Report

    Report Number
    1526439-2003-00085
    Event Type
    Injury
    Date Received
    November 7, 2003
    Date of Event
    October 31, 2003
    Manufacturer
    DEPUY SPINE
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PORTION OF THE DEPUY SPINE LEOPARD IMPLANT WAS BROKEN DURING INSERTION. PIECE WAS REMOVED AND THE SURGEON FELT THAT THERE WAS NO PROBLEM WITH THE INTEGRITY OF THE DEVICE. NO PT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEOPARD 9MM VBR IMPLANT VBR IMPLANT JDN DEPUY SPINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention