BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW

    MDR report key: 3172725 · Received June 17, 2013

    Report

    Report Number
    0001032347-2013-00202
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK980512
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL FILE STATED IN DEVICE NAME IN ERROR. THE SPECIFIC PART INFORMATION IS UNKNOWN. DEVICE NAME WAS UPDATED TO READ "BONE SCREW". THERE WERE NO OTHER CHANGES TO CONTENT OR EVENT ADDED TO FILE.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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

    FILE UDATED AS SPECIFIC PART INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    THE SCREW BROKE DURING SURGERY AND COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273681 BONE SCREW SCREW HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization