BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN LONG GAMMA NAIL CASE 4

    MDR report key: 10889936 · Received November 24, 2020

    Report

    Report Number
    0009610622-2020-00765
    Event Type
    Death
    Date Received
    November 24, 2020
    Date of Event
    October 15, 2013
    Report Date
    November 23, 2020
    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.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY DEPARTMENT OF ORTHOPAEDIC SURGERY AND TRAUMATOLOGY AT HOSPITAL CLÍNICO SAN CARLOS IN SPAIN. THE TITLE OF THIS REPORT IS ¿BENEFITS OF EARLY INTRAMEDULLARY NAILING IN FEMORAL METASTASES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA NAILING¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1007/S00264-013-2108-X. THIS REPORT INCLUDES RESEARCH DONE ON 65 PATIENTS BETWEEN THE PERIODS FROM 1995 TO 2011. 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 5 CASES OF DEATH DUE TO RESPIRATORY FAILURE WHICH OCCURRED IMMEDIATE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364016 UNKNOWN LONG GAMMA NAIL CASE 4 IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death