BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSTEON SCREW

    MDR report key: 413341 · Received August 28, 2002

    Report

    Report Number
    9617083-2002-00011
    Event Type
    Other
    Date Received
    August 28, 2002
    Date of Event
    June 18, 2002
    Report Date
    August 27, 2002
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING SURGERY AN INFECTION WAS FOUND AT SITE. MANY OTHER INSTRUMENTS AND PRODUCTS WERE USED DURING THE PROCEDURE. CAUSE OF INFECTION UNASCERTAINED INITIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON SCREW INTERFERENCE SCREW HWC BIOCOMPOSITES LTD 10 X 28MM 03/02-PH263

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention