BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2601120 · Received May 24, 2012

    Report

    Report Number
    9617083-2012-00008
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 23, 2012
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: BASED ON THE LIMITED AMOUNT OF INFO RECEIVED, SUSPECTED ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON OPENED THE PACKS, 2 SCREWS WERE ALREADY BROKEN. THE PACKS WERE NOT OPENED UNTIL COMMENCING THE CASE. THE SCREWS WERE IN THE SAME CASE AND HAD BEEN STORED AT THE HOSPITAL. THERE WAS ONLY A SLIGHT DELAY AND THE SURGERY WAS COMPLETED USING ANOTHER BIO-ABSORBABLE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0511PH135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention