BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLAG REAMER

    MDR report key: 7407745 · Received April 9, 2018

    Report

    Report Number
    3011580264-2018-00001
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    October 26, 2017
    Report Date
    April 9, 2018
    Manufacturer
    IN2BONES-USA, LLC
    Product Code
    HTO
    PMA / PMN Number
    K170518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING A CRISSCROSS FUSION, THAT THE DISTAL TIP OF THE REAMER BROKE OFF. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN PIECE THUS LEAVING THE BROKEN FRAGMENT IN THE PATIENT. THE SURGEON MADE THE DECISION NOT TO IMPLANT THE SECOND SCREW. THE HOSPITAL DISPOSED OF THE REAMER THUS NO PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER DETAILS ARE KNOWN AT THIS TIME. NO PRODUCT WAS RETURNED FOR EVALUATION THEREFORE NO CONCLUSIONS TO THE CAUSE OF THE EVENT CAN BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRISSCROSS FUSION, THAT THE DISTAL TIP OF THE REAMER BROKE OFF. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN PIECE THUS LEAVING THE BROKEN FRAGMENT IN THE PATIENT. THE SURGEON DECIDED NOT TO IMPLANT THE SECOND SCREW. THE HOSPITAL DISPOSED OF THE REAMER THUS NO PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250579 COLAG REAMER REAMER HTO IN2BONES-USA, LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention