BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 26MM

    MDR report key: 4083579 · Received September 12, 2014

    Report

    Report Number
    2520274-2014-13620
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    August 13, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PK131186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT DISTAL TIBIA ON (B)(6) 2014 AND RETURNED TO THE EMERGENCY ROOM ON (B)(6) 2014 WITH WOUND DEHISCENCE OVER THE MEDIAL PLATE. THE PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2014 FOR IRRIGATION AND DEBRIDEMENT OF THE RIGHT MEDIAL ANKLE WOUND AND REMOVAL OF THE HARDWARE. THE HARDWARE WAS SUCCESSFULLY REMOVED, NO NEW HARDWARE WAS IMPLANTED AND THE PATIENT WAS TREATED FOR POSSIBLE INFECTION. THE REPORT INDICATED THE PATIENT IS STABLE WITH NO FURTHER COMPLICATIONS. IT WAS REPORTED THE REMOVED HARDWARE WAS INTACT AND THERE WAS NO BROKEN HARDWARE. THIS IS REPORT 18 OF 21 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564679 3.5MM CORTEX SCREW SELF-TAPPING 26MM SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention