BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 3940739 · Received July 17, 2014

    Report

    Report Number
    0008010177-2014-00183
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE RECEIVED X-RAY THE REPORTED EVENT THAT THE SCREWS WERE BROKEN COULD BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION AND THE RECEIVED X-RAY HAS POOR IMAGE QUALITY AND RESOLUTION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT FOLLOW UP IN MD OFFICE. OBSERVED BROKEN SCREWS IN DISTAL PORTION OF RIGHT VARIAX DISTAL RADIUS PLATE

    Description of Event or Problem · 1

    PT FOLLOW UP IN MD OFFICE. OBSERVED BROKEN SCREWS IN DISTAL PORTION OF RIGHT VARIAX DISTAL RADIUS PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417928 UNKNOWN_FRO_PRODUCT IMPLANT FRO STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other