BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4152036 · Received October 8, 2014

    Report

    Report Number
    2520274-2014-13969
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW/UNKNOWN LOT. UNKNOWN DATE IN (B)(6) 2014. PART OF DEVICE REMAINED IN PATIENT; DEVICE WAS NOT EXPLANTED. 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 THERE WAS A REVISION PROCEDURE DUE TO A NONUNION AND THE MOST DISTAL LOCKING SCREW FAILED; THE HEAD OF THE SCREW BROKE OFF AND THE PLATE WAS PROTRUDING. THE HEAD OF THAT SCREW WAS REMOVED AND THE SHAFT REMAINED IN THE PATIENT. THREE CORTEX SCREWS WERE ALSO REMOVED. THE PLATE REMAINED IN THE PATIENT AND NEW SCREWS WERE INSERTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632678 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention