BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1780995 · Received July 28, 2010

    Report

    Report Number
    2520274-2010-00146
    Event Type
    Injury
    Date Received
    July 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT IMPLANTED WITH LCP CONDYLAR PLATE, SCREW AND CABLES FOR A COMMINUTED MIDSHAFT RIGHT FEMUR FRACTURE. PT EXPERIENCED POSTOP BREAKAGE OF THE PLATE, A BROKEN SCREW HEAD AND TWO LOOSE CABLES. HARDWARE WAS REMOVED. PT WAS REVISED TO A LARGER PLATE, ALONG WITH SCREWS, CABLES AND POSSIBLE ALLOGRAFT STRUT. THIS IS THE 2ND OF 4 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention CABLES| SCREWS| PLATE