BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN APEX PIN

    MDR report key: 9930801 · Received April 6, 2020

    Report

    Report Number
    0008031020-2020-01092
    Event Type
    Death
    Date Received
    April 6, 2020
    Date of Event
    January 1, 2004
    Report Date
    April 6, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS BEEN REPORTED DURING A LITERATURE REVIEW PERFORMED BY THE POST MARKET SURVEILLANCE GROUP. 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 LITERATURE FROM HAUKELAND UNIVERSITY HOSPITAL, NORWAY. THE TITLE OF THIS REPORT IS ¿EXTERNAL FIXATION OF FRACTURES OF THE DISTAL RADIUS A RANDOMIZED COMPARISON OF THE HOFFMAN COMPACT II NON-BRIDGING FIXATOR AND THE DYNAWRIST FIXATOR IN 75 PATIENTS FOLLOWED FOR 1 YEAR¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿HOFFMAN II COMPACT¿ SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM JANUARY 2004 TO DECEMBER 2005. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE/PATIENT DETAILS FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 14 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DEATH AFTER THE 6-WEEK FOLLOW-UP. 1 OUT OF 2 CASES. THE REPORT STATES: ¿2 PATIENTS DIED AFTER THE 6-WEEK FOLLOW-UP¿ CAUSE AND DATE OF THE DEATH ARE UNKNOWN AND WILL NOT BE DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390776 UNKNOWN APEX PIN IMPLANT JDW STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death