BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    MDR report key: 2971388 · Received February 21, 2013

    Report

    Report Number
    0009610622-2013-00056
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE IS NOT AVAILABLE, HOSPITAL POLICY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF A GAMMA NAIL. PATIENT WAS EXPERIENCING PAIN FROM THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75378 UNKNOWN_OSTEOSYNTHESIS_PRODUCT IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention