BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.5X4MM HT SD X-DRIVE SCREW

    MDR report key: 1339179 · Received March 5, 2009

    Report

    Report Number
    1032347-2009-00033
    Event Type
    Other
    Date Received
    March 5, 2009
    Date of Event
    February 26, 2009
    Report Date
    March 1, 2009
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K953385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. "INTRAOPERATIVE FRACTURE OF SCREWS CAN OCCUR IF EXCESSIVE FORCE (TORQUE) IS APPLIED WHILE SEATING BONE SCREW." UNABLE TO CONFIRM THIS IS WHAT OCCURRED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANEURYSM CLIPPING, WHILE ATTEMPTING TO INSERT A SCREW, IT BROKE AND A PORTION OF THE SCREW REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5X4MM HT SD X-DRIVE SCREW BONE SCREW JEY BIOMET MICROFIXATION

    Patients

    Seq Age Sex Outcome Treatment
    1