BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILOK SCREW

    MDR report key: 369165 · Received December 28, 2001

    Report

    Report Number
    MW1023717
    Event Type
    Injury
    Date Received
    December 28, 2001
    Date of Event
    December 5, 2001
    Report Date
    December 18, 2001
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ACL PROCEDURE A HAMSTRING GRAFT WAS SHREDDED AND REQUIRED RESUTURING. CONTRARY TO MFR'S INSTRUCTIONS IN IFU, SURGEON USED A THRADED TAP TO DILATE THE TUNNEL INSTEAD OF A DILATOR. RE-SUTURED GRAFT WAS RE-INSERTED INTO TUNNEL WITH MINIMAL TIME DELAY. DURING SCREW INSERTION, DILATOR WAS NOT USED, DRIVER BENT AND SCREW HEAD SHEARED. SCREW WAS INSERTED FULLY AND SURGEON DEEMED GOOD GRAFT FIXATION WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59055 BILOK SCREW ACL INTERFERENCE SCREW HWC BIOCOMPOSITES LTD 101925 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention