BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AXSOS 3 TI DISTAL MEDIAL TIBIA LOCKING PLATE

    MDR report key: 9512168 · Received December 23, 2019

    Report

    Report Number
    0008031020-2019-02323
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    July 1, 2016
    Report Date
    February 26, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO B2, B5, D1 (AS REPORTED UNKNOWN PRODUCT LONG DESCRIPTION WAS REVISED TO AXSOS 3 TI DISTAL MEDIAL TIBIA LOCKING PLATE). H6 (PATIENT CODES).

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A PMCF FROM JAMES COOK UNIVERSITY HOSPITAL, UK. THE TITLE OF THIS REPORT IS ¿STRYKER PME AXSOS PATIENT REVIEW¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿AXSOS 3TI PLATING¿ SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM (B)(6) 2016 2016 ¿ (B)(6) 2018. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE 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 30 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES INFECTED NON-UNION & REMOVAL OF METAL PLUS FRAME.

    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 PMCF FROM (B)(6) UNIVERSITY HOSPITAL, (B)(6). THE TITLE OF THIS REPORT IS ¿STRYKER PME AXSOS PATIENT REVIEW¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿AXSOS 3TI PLATING¿ SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM JULY 2016 ¿ MAY 2018. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE 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 30 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES NONUNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306640 UNKNOWN AXSOS 3 TI DISTAL MEDIAL TIBIA LOCKING PLATE IMPLANT HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R