BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSON

    MDR report key: 17725914 · Received September 11, 2023

    Report

    Report Number
    3011390763-2022-00001
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    January 6, 2020
    Report Date
    January 16, 2022
    Manufacturer
    NEXUS SPINE, LLC
    Product Code
    MNI
    PMA / PMN Number
    160820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: PEDICLE SCREW DISASSEMBLED. THE PEDICLE SCREW REMOVED SHOWED DAMAGE POSSIBLY DUE TO A BONE REMOVAL INSTRUMENT. OTHER REMARKS: COMPLAINT FOLLOW-UP FROM REMEDIATION ACTIVITIES RESULTING IN LATE FILING.

    Description of Event or Problem · 0

    PATIENT HOSPITALIZED FOR REMOVAL AND REPLACEMENT OF DISASSEMBLED PEDICLE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118557 PRESSON PEDICLE SCREW MNI NEXUS SPINE, LLC 520225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention