BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2974442 · Received February 22, 2013

    Report

    Report Number
    2520274-2013-01148
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS IMPLANTED APPROXIMATELY (B)(6)2012. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PLATE AND SCREWS ON APPROXIMATELY (B)(6) 2012. PATIENT RETURNED TO A DIFFERENT SURGEON AND IT WAS DISCOVERED THERE WAS A NONUNION, DATE UNKNOWN. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REMOVAL OF THE HARDWARE. IT WAS DISCOVERED DURING THE REMOVAL THAT ONE SCREW WAS BROKEN. PATIENT REVISED TO ORIF OF THE TIBIA AND FIBULA. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 15 OF 15 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78586 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention