BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM NON- LOCKING SCREW

    MDR report key: 2033468 · Received March 23, 2011

    Report

    Report Number
    2520274-2011-00077
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Report Date
    March 3, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. DEVICE WAS NOTE EXPLANTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH HARDWARE (B)(6) 2010 FOR A LATERAL SAGITTAL SPLIT PROCEDURE. ON F/U VISIT, IT WAS NOTED THAT THE SCREW HAD MIGRATED. SCREW REMAINS IMPLANTED IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4MM NON- LOCKING SCREW NON- LOCKING SCREW HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI