BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3944593 · Received July 18, 2014

    Report

    Report Number
    2520274-2014-12642
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN SCREW/UNKNOWN LOT NUMBER. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO A FRACTURE COLLAPSE. THE PATIENT PREVIOUSLY UNDERWENT A 3.5 MM PROXIMAL TIBIAL PLATE SURGERY THREE MONTHS AGO. THE FRACTURE COLLAPSED BECAUSE PATIENT DIDN'T FOLLOW DIRECTIONS AND WALKED ON TOO SOON. NO PRODUCT PROBLEM AND NOTHING WRONG WITH HARDWARE. THIS REPORT IS FOR ONE UNKNOWN SCREW. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422510 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention