BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURFIX STE S. STEEL DIA 3.5 L28MM STERILE

    MDR report key: 3940216 · Received June 19, 2014

    Report

    Report Number
    9615741-2014-00033
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    PMA / PMN Number
    K093914
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO REPORTS CONCERNING THE SAME PATIENT. THIS REPORT CONCERNS THE UNI-CP SCREWS PRODUCT ID (B)(4). IT WAS REPORTED "TWO UNI-CP SCREWS BROKE ON THE CC JOINT AND HAD TO BE REMOVED. BOTH THE PLATE AND TWO OF THE SCREWS BROKE. THERE WAS ALSO A SYNTHES 7.3 SCREW THAT BROKE AS WELL." ADDITIONAL INFORMATION WAS REQUESTED NUMEROUS TIMES BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359726 SURFIX STE S. STEEL DIA 3.5 L28MM STERILE ADVANSYS HRS NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention