BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM CANNULATED LOCKING SCREW70MM

    MDR report key: 3579832 · Received January 16, 2014

    Report

    Report Number
    2520274-2014-00202
    Event Type
    Injury
    Date Received
    January 16, 2014
    Report Date
    December 27, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CONCOMITANT PRODUCTS: HTY; JDW; HRS. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A FEMALE PATIENT UNDERWENT EXPLANTATION. IT WAS REPORTED THAT A CONDYLAR PLATE WAS BROKEN AT THE DISTAL AREA OF THE PLATE AROUND THE LOCKING SCREW. THERE WERE NO REPORTS OF ANY BREAKAGE OF THE SCREWS. UNSPECIFIED PATHOLOGY TESTS WERE PERFORMED WHICH SHOWED RESULTS INDICATING THE PRESENCE OF INFECTION. IT WAS REPORTED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42474 5.0MM CANNULATED LOCKING SCREW70MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention