BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01912

    MDR report key: 3052016 · Received April 11, 2013

    Report

    Report Number
    2520274-2013-01912
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. EXPLANT DATE (B)(6) 2013. RECEIVED BY MANUFACTURE ON 3/18/2013 FROM HOSPITAL COMPLETED QUESTIONNAIRE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH LCP WRIST FUSION PLATE AND UNSPECIFIED QUANTITY OF SCREWS CONSTRUCT ON AN UNSPECIFIED DATE. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 AFTER X-RAYS TAKEN ON AN UNSPECIFIED DATE REVEALED TWO SCREWS WERE BROKEN AT THE BODY OF THE SCREWS BELOW THE PLATE HOLES. SURGEON REMOVED PLATE AND SCREWS BUT LEFT THE FRAGMENTED BODY OF THE 2 SCREWS IMPLANTED IN ORDER TO PREVENT BONE VOIDS. PROCEDURE WAS COMPLETED TO THE SATISFACTION OF THE SURGEON. IT WAS REPORTED THAT PATIENT NON COMPLIANT ACTIVITIES MAY HAVE CONTRIBUTED TO THE SCREWS BREAKING. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS 2 OF 2 REPORTS FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156540 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention