BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 1272527 · Received December 17, 2008

    Report

    Report Number
    MW5009326
    Event Type
    Injury
    Date Received
    December 17, 2008
    Date of Event
    November 11, 2008
    Report Date
    December 9, 2008
    Manufacturer
    SYNTHES INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGERY DONE FOR REMOVAL OF BROKEN CLAVICLE PLATE AND SCREWS. PATIENT STATES SHE DID NOT EXPERIENCE A DIRECT INJURY CAUSING THE PLATE TO BREAK. AFTER SHE EXPERIENCED A POP AND SIGNIFICANT PAIN, SHE PRESENTED TO THE CLINIC AND HARDWARE FAILURE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES CLAVICLE SCREWS HWC SYNTHES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention