BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSON

    MDR report key: 15028932 · Received July 15, 2022

    Report

    Report Number
    3011390763-2022-00003
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    June 14, 2022
    Report Date
    July 14, 2022
    Manufacturer
    NEXUS SPINE, LLC
    Product Code
    MNI
    UDI-DI
    B6785206210
    PMA / PMN Number
    160820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RADIOGRAPHS PROVIDED CONFIRM THE REPORTED EVENT. ON THE LEFT SIDE, THE 22MM HYBRID COUPLER [P/N 520611, LOT H064698] PULLED APART FROM THE DEVICES CRANIAL AND CAUDAL TO IT. ON THE RIGHT SIDE, THE 18MM HYBRID COUPLER [P/N 520609, LOT 061295] STAYED JOINED TO THE 28MM TELE ROD [P/N 520621, LOT 060783] BUT THE TWO PULLED APART FROM THE DEVICES CRANIAL AND CAUDAL TO THEM. THE EXPLANTED DEVICES WERE NOT RETURNED TO ALLOW FOR FURTHER EVALUATION; THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED. DHR REVIEW - NO MATERIAL NON-CONFORMANCES, NO MANUFACTURING ERRORS, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, DIMENSIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE.

    Description of Event or Problem · 0

    PATIENT HOSPITALIZED FOR REMOVAL OF DISASSEMBLED ROD COUPLERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047713 PRESSON PEDICLE SCREW SYSTEM MNI NEXUS SPINE, LLC 520621 060783 B6785206210

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention