BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 3855870 · Received May 1, 2014

    Report

    Report Number
    2249697-2014-00005
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    January 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    RO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED TO SALES MANAGER THAT AN IMPLANTED BIOSTEON INTERFERENCE SCREW WAS BROKEN, VERY CLOSE TO THE TIP OF THE SCREW, AT 7 MONTHS AFTER THE IMPLANTATION. THE RESPECTIVE SCREW WAS EXPLANTED AND SENT BY DOCTOR TO A THIRD PARTY ((B)(4)) FOR MICROSCOPIC ANALYZE. IT WAS FURTHER REPORTED THAT SCREW IS GOING TO BE RETURNED FOR MANUFACTURER'S INVESTIGATION AS SOON AS IT WILL BE SENT BACK TO DOCTOR AND THEREFORE IT MIGHT BECOME AVAILABLE FOR RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262127 BIOSTEON WEDGE INTERFERENCE SCREW SCREW, FIXATION, BONE HWC BIOCOMPOSITES LTD 0312PH132

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R