BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONICAL SCREW

    MDR report key: 2882231 · Received December 20, 2012

    Report

    Report Number
    2520274-2012-04239
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PART OR LOT NUMBER WAS PROVIDED AND THE PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A PATIENT WHO WAS IMPLANTED ON (B)(6) 2011 WITH AN LCP PROXIMAL TIBIA PLATE AND SCREWS TO TREAT A LEFT TIBIAL PLATEAU FRACTURE. POSTOPERATIVELY, THE PATIENT COMPLAINED OF PAIN OVER THE IMPLANT SITE. THE PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. IT IS REPORTED THAT THE FRACTURE HAD HEALED. THIS IS REPORT #5 OF 5 FOR THE SAME EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention