BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEINMANN PIN

    MDR report key: 24569751 · Received March 11, 2026

    Report

    Report Number
    MW5185073
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    January 19, 2026
    Report Date
    March 5, 2026
    Manufacturer
    CHOICE SPINE, LLC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PLACING SCREWS FOR AN SI-JOINT FUSION, STEINMANN PIN BROKE, LEAVING AN 8MM RETAINED PIN FRAGMENT. THE PIN TIP COULD NOT BE REMOVED (FRAGMENT). IT WAS NEAR THE NERVE ROOT. THE PATIENT HAD RESULTANT LS NEUROPRAXIA AND WEAK EXTENSORS OF HER FOOT AS A RESULT. DUE TO LOCATION OF THE RETAINED PIN, IT WOULD BE INADVISABLE TO REMOVE THE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635099 STEINMANN PIN ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CHOICE SPINE, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Hospitalization 12 MM DRILL. | STEINMANN PIN 12".