BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO

    MDR report key: 2071533 · Received April 14, 2011

    Report

    Report Number
    2071533
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING ACL RECONSTRUCTION, MILAGRO INTERFERENCE SCREW 7X23 BROKE IN HALF ON THE FEMUR SIDE. NO X-RAY WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILAGRO SCREW, INTERFERENCE HWC DEPUY ORTHOPAEDICS, INC 231800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR