BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2872678 · Received December 7, 2012

    Report

    Report Number
    2520274-2012-03687
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT LOT 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

    HOSPITAL SURGEON REPORTED: PATIENT TREATED FOR CABG AND WAS IMPLANTED WITH STERNAL PLATE AND SCREWS ON (B)(6) 2012. PATIENT PRESENTED TO SURGEON WITH INFECTION ON AN UNKNOWN DATE. FURTHER EXAMINATION SHOWED THE EMERGENCY RELEASE PIN ON THE STERNAL PLATE MIGRATED AND THE PLATE PULLED APART. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012, ALL HARDWARE WAS REMOVED. PATIENT WAS NOT REVISED TO ANY NEW HARDWARE; A WOUND VAC WAS PLACED TO TREAT THE INFECTION. FUTURE ANTICIPATED TREATMENT IS UNKNOWN. THIS IS 5 OF 7 REPORTS FOR THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention PLATE| SCREW