BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM LOCKING SCREW SELF-DRILLING 26MM

    MDR report key: 2963579 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-00977
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 19, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN INVESTIGATION AND DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO LOT NUMBER WAS PROVIDED AND THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A PATIENT WHO WAS IMPLANTED WITH ONE PLATE AND NINETEEN SCREWS ON (B)(6) 2011, TO TREAT A RIGHT DISTAL FEMUR FRACTURE. THE PATIENT HAD ALL OF THE HARDWARE REMOVED ON (B)(6) 2013, DUE TO A NON-UNION IN THE RIGHT DISTAL FEMUR. REPORTEDLY, THE FRACTURE WAS NOT HEALED. THE SURGEON TOOK CULTURES FROM THE PATIENT, SUSPECTING A POSSIBLE INFECTION. THE SURGEON DID NOT REPLACE THE EXPLANTED PARTS WITH ANY NEW HARDWARE. IT WAS REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITHOUT INCIDENT. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND IV THERAPY. THIS IS REPORT NUMBER 14 OF 20 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68193 5.0MM LOCKING SCREW SELF-DRILLING 26MM LOCKING SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention