BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/INSERTION DHS BLADE

    MDR report key: 3113312 · Received May 15, 2013

    Report

    Report Number
    2520274-2013-02539
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    August 10, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, RUST WAS DISCOVERED ON A CONNECTING SCREW FOR INSERTION OF DHS BLADE. THE EVENT OCCURRED WHEN THE SCREW WAS WASHED FOR THE FIRST TIME. IT WAS REPORTED OTHER INSTRUMENTS WASHED AT THE SAME TIME DID NOT EXHIBIT ANY RUST. THIS IS REPORT IS FOR A CONNECSCR F/INSERTION DHS BLADE. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214023 CONNECSCR F/INSERTION DHS BLADE LXH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1