BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2142895 · Received June 22, 2011

    Report

    Report Number
    2520274-2011-00214
    Event Type
    Injury
    Date Received
    June 22, 2011
    Report Date
    June 6, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. UNABLE TO PROVIDE THE MFR, PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. W/O A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    CONSULTANT REPORTED: PT STATUS POST PLATE AND SCREW IMPLANTATION C3-C7: SURGEON NOTED PTS POOR BONE QUALITY AND RETURNED PT TO OPERATING ROOM (B)(6) 2011 FOR REMOVAL OF HARDWARE, PLATE AND 10 SCREWS. PT WAS REVISED TO CORPECTOMY OF C5, HEMI-CORPECTOMY OF C6, FUSION WITH PLATE, SCREWS AND SYNMESH FROM C3 TO T1. THIS IS ELEVEN OF ELEVEN REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI SCREW KWP SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention PLATE