BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 19498068 · Received June 10, 2024

    Report

    Report Number
    1220246-2024-05381
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    August 11, 2020
    Report Date
    June 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    PMA / PMN Number
    K202099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023.  ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WHERE A DEVICE FROM A DIFFERENT MANUFACTURER WAS IMPLANTED. THAT DEVICE LATER BROKE AND A REVISION PROCEDURE WAS PERFORMED USING THE ARTHREX GALILEO SYSTEM. THE GALILEO LAG SCREW THAT WAS IMPLANTED DURING THE REVISION ALSO BROKE AND THE PATIENT IS NOW SCHEDULED FOR A 2ND REVISION ON (B)(6) 2021 WHERE THE LAG SCREW WILL BE REMOVED. ADDITIONAL INFORMATION PROVIDED 6/16/21: THE GALILEO WAS IMPLANTED ON (B)(6) 2020, DUE TO A REVISING OF A BROKEN GAMMA NAIL. THE SURGEON WAS AWARE OF THE BROKE GAMMA NAIL ON 6/8/21. THE REVISION OF THE GALILEO LAG SCREW WILL TAKE PLACE ON (B)(6) 2021 IN TEMPLE, TEXAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173226 UNK INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown