BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN T2 PROXIMAL HUMERAL NAIL

    MDR report key: 11757195 · Received April 30, 2021

    Report

    Report Number
    0009610622-2021-00462
    Event Type
    Death
    Date Received
    April 30, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 30, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. 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. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A PMCF CONDUCTED BY (B)(6) UNIVERSITY HOSPITAL IN (B)(6). THE TITLE OF THIS REPORT IS ¿RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF HUMERAL FRACTURES WITH THE T2 PROXIMAL HUMERAL NAILING SYSTEM (PHN)¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 PROXIMAL HUMERAL NAILING (PHN)¿ SYSTEM. THIS REPORT INCLUDES RESEARCH DONE ON 96 PATIENTS FROM THE PERIOD JANUARY 2011 TO JULY 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DEATH. THE REPORT STATES ONE PATIENT DIED IN THE IMMEDIATE POSTOPERATIVE PERIOD DUE TO PULMONARY THROMBOEMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649915 UNKNOWN T2 PROXIMAL HUMERAL NAIL IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death