BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.5X5MM HT SD X-DRIVE SCREW

    MDR report key: 1416609 · Received April 10, 2009

    Report

    Report Number
    1032347-2009-00046
    Event Type
    Other
    Date Received
    April 10, 2009
    Report Date
    March 27, 2009
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 A CONCLUSION CAN BE DRAWN, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEAD OF A SCREW SHEARED OFF DURING SURGERY. A PORTION OF THE SCREW REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5X5MM HT SD X-DRIVE SCREW BONE SCREW HRS BIOMET MICROFIXATION

    Patients

    Seq Age Sex Outcome Treatment
    1