BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3922579 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12443
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN 3.5MM CORTEX SCREW. SCREW WAS NOT COMPLETELY EXPLANTED, FRAGMENT REMAINS IMPLANTED IN PATIENT¿S BONE. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 3.5 MM CORTEX SCREW BROKE DURING A HARDWARE REMOVAL. THE HARDWARE REMOVAL WAS DUE TO PATIENT HEALING. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2014. THE PLATE AND REMAINING FIVE CORTEX SCREWS WERE COMPLETELY REMOVED. THE BROKEN PORTION REMAINS IN THE PATIENT. THIS REPORT IS FOR AN UNKNOWN 3.5 MM CORTEX SCREW THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401889 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR