BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3922721 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12452
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED IN A VETERINARY CASE. NO PATIENT INFORMATION WILL BE REPORTED. THIS REPORT IS FOR TWO UNKNOWN 2.0 STARDRIVE CORTEX SCREW. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DOCTOR HAS BEEN USING A DCP-PLATE WITH STARDRIVE Ø 2.0MM CORTICAL SCREWS. IN TWO VETERINARY CASES NOW THE PLATE HAS BEEN BROKEN AND SCREW HAS GONE THROUGH THE PLATE. THE DOCTOR WOULD LIKE TO KNOW IF THE SCREW HEAD IS TOO SMALL FOR THE PLATE. IT WAS REPORTED THAT BOTH PLATES WERE BROKEN AFTER SURGERY. THIS A VETERINARY CASE, THERE WAS NO HUMAN PATIENT INVOLVED. THIS REPORT IS FOR TWO UNKNOWN 2.0 STARDRIVE CORTEX SCREW. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401352 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1