BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4100684 · Received September 19, 2014

    Report

    Report Number
    2520274-2014-13726
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 22, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 10 UNKNOWN CORTICAL SCREWS. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 MALE PATIENT UNDERWENT REMOVAL OF A CALCANEAL PLATE AND TEN CORTICAL SCREWS ON (B)(6) 2014. THE PATIENT INITIALLY HAD A CALCANEAL PLATE IMPLANTED SEVERAL YEARS AGO. THE EXACT IMPLANT DATE IS NOT KNOWN. THE PATIENT SUBSEQUENTLY EXPERIENCED A FRACTURE OF THE TALUS. THE CALCANEAL PLATE AND CORTICAL SCREWS WERE COMPLETELY REMOVED; ALL HARDWARE WAS REPORTED AS FULLY INTACT. THE PATIENT WAS REVISED TO A SUBTALAR FUSION USING 6.5 MILLIMETER HEADLESS SCREWS. THIS REPORT IS FOR AN 10 UNKNOWN CORTICAL SCREWS. THIS IS REPORT NUMBER 2 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581759 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention