BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSON

    MDR report key: 20260036 · Received September 19, 2024

    Report

    Report Number
    3011390763-2024-00002
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 19, 2024
    Manufacturer
    NEXUS SPINE, LLC
    Product Code
    MNI
    UDI-DI
    B6785206290
    PMA / PMN Number
    K223529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RADIOGRAPHS PROVIDED CONFIRM THE REPORTED EVENT, THAT THE CONSTRUCT WAS NOT ASSEMBLED. THE ROD (P/N 520629, LOT 055877) LOCATED ON THE CRANIAL LEFT SIDE WAS OBSERVED UNDER FLUOROSCOPY AS BEING DISASSOCIATED FROM THE COUPLER. THE ROOT CAUSE WAS THAT THE CONSTRUCT EXCEEDED THE POLYAXIAL LIMIT. THE EXPLANTED DEVICES WERE NOT RETURNED TO ALLOW FOR FURTHER EVALUATION. DHR REVIEW - NO MATERIAL NON-CONFORMANCE'S, 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 AND REPLACEMENT OF DISASSEMBLED ROD AND COUPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746636 PRESSON PEDICLE SCREW SYSTEM MNI NEXUS SPINE, LLC 520629 055877 B6785206290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention