BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 3894514 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12121
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 1 LOW PROFILE 3.5 CORTEX SCREW, PART AND LOT NUMBER UNKNOWN WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 A PATIENT WENT TO THE OPERATING ROOM FOR HARDWARE REMOVAL ON (B)(6) 2014 DUE TO PAIN ONLY, THE FRACTURE HAD HEALED. THE PATIENT COMPLAINED OF PAIN AT THE SURGICAL SITE AND WANTED THE HARDWARE THAT WAS IMPLANTED ON (B)(6) 2013 REMOVED FROM HER LEFT PROXIMAL LATERAL TIBIA AND FROM HER DISTAL FIBULA AND MEDIAL MALLEOLUS, ALL HARDWARE SUCCESSFULLY REMOVED. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR 1 LOW PROFILE 3.5 CORTEX SCREW, PART AND LOT NUMBER UNKNOWN. THIS IS REPORT 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371858 SCREW,FIXATION,BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention