BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELOUS LOCKING SCREW 2.4MM

    MDR report key: 2010975 · Received March 8, 2011

    Report

    Report Number
    1032347-2011-00029
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K0110076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENGTH OF SCREW UNKNOWN, THEREFORE ENTIRE CATALOG NUMBER UNKNOWN. IT WAS COMMENTED DURING THE REVISION SURGERY, THE STERNUM WAS NOT APPROXIMATED CORRECTLY, APPEARED THE LEFT SIDE WAS POSITIONED SUPERIOR TO THE RIGHT SIDE. 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 REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PLATES AND SCREWS IMPLANTED FOR STERNAL CLOSURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 TO REPOSITION A PLATE AND ADD ANOTHER PLATE, DURING THE REVISION SURGERY, IT WAS NOTED A SCREW WAS NOT LOCKING INTO THE PLATE AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELOUS LOCKING SCREW 2.4MM BONE SCREW HWC BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization