BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 50MM

    MDR report key: 3981872 · Received August 5, 2014

    Report

    Report Number
    2520274-2014-12977
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 REVISION PROCEDURE OCCURRED DUE TO A PATIENT EXPERIENCING PAIN. ON (B)(6) 2013, THE PATIENT FELL AND EXPERIENCED AN ANKLE FRACTURE. ON (B)(6) 2013, AN INITIAL PROCEDURE WAS PERFORMED TO FIX THE FRACTURE USING ONE UNKNOWN FIBULA PLATE, TWO UNKNOWN MEDIAL MAL SCREWS AND TWO 3.5MM CORTEX SCREWS (SYNDESMOSIS SCREWS, ONE 50MM LONG AND ONE 55MM LONG). ON (B)(6) 2014, THE PATIENT RETURNED FOR A FOLLOW-UP VISIT WITH THE SURGEON AND REPORTED PAINFUL HARDWARE. THE DECISION WAS MADE TO EXPLANT THE TWO SYNDESMOSIS SCREWS. ON (B)(6) 2014, A REVISION PROCEDURE WAS PERFORMED TO REMOVE THE PAINFUL HARDWARE. IT WAS REPORTED THAT THE FRACTURE HAD HEALED AND THERE WERE NO ISSUES WITH THE REMOVAL OF THE HARDWARE, ONLY THE TWO SYNDESMOSIS SCREWS WERE REMOVED. THE PLATE AND THE MEDIAL MAL SCREWS REMAINED IN THE PATIENT. THERE WERE NO ISSUES REPORTED WITH ANY OF THE HARDWARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM REPORTED. THERE WAS NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR 1 OF THE CORTEX SCREWS. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458692 3.5MM CORTEX SCREW SELF-TAPPING 50MM SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention