BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSON

    MDR report key: 16473265 · Received March 2, 2023

    Report

    Report Number
    3011390763-2023-00001
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    February 3, 2023
    Report Date
    March 2, 2023
    Manufacturer
    NEXUS SPINE, LLC
    Product Code
    MNI
    UDI-DI
    B6785206320
    PMA / PMN Number
    160820
    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 END COUPLER (P/N 520147, LOT G86337) LOCATED ON THE CRANIAL LEFT SIDE WAS OBSERVED UNDER FLUOROSCOPY AS HAVING DISASSOCIATED FROM THE TELESCOPING ROD (P/N 520632, LOT 59176). 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. THE PRODUCT RELATED DEVIATION DID NOT INTRODUCE, ADD OR CONTRIBUTE TO ADDITIONAL PRODUCT RISK.

    Description of Event or Problem · 0

    PATIENT HOSPITALIZED FOR REMOVAL OF DISASSEMBLED END COUPLER AND TELESCOPING ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503884 PRESSON PEDICLE SCREW SYSTEM MNI NEXUS SPINE, LLC 520632 59176 B6785206320

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention