BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATIN, BONE

    MDR report key: 5107467 · Received September 28, 2015

    Report

    Report Number
    2520274-2015-16146
    Event Type
    Injury
    Date Received
    September 28, 2015
    Report Date
    September 14, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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

    REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT AFTER THE APPLICATION OF PLATE DISTALLY WITH LOCKING SCREWS, AND FIXATION PROXIMAL WITH SCREWS, THE DISTAL FRAGMENT TENDS TO DISPLACE, MAKING A GAB BETWEEN THE PLATE AND THE DISTAL RADIUS. THE PATIENTS HAD THE VA2CP REMOVED TO AVOID TENDON-RUPTUR. NO PATIENTS HAD TENDON-RUPTUR. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638486 SCREW, FIXATIN, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention