BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL USA TRAY / SPINAL S-LOK SCREW

    MDR report key: 9525012 · Received December 26, 2019

    Report

    Report Number
    MW5091901
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    December 20, 2019
    Report Date
    December 23, 2019
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LAMINECTOMY PROCEDURE AN S-LOK IMPLANT SCREW BROKE DURING IMPLANTATION. ALL PIECES REMOVED FROM PT AND NO HARM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316747 SPINAL USA TRAY / SPINAL S-LOK SCREW ORTHOSIS, SPINAL PEDICLE FIXATION MNI PRECISION SPINE, INC. SLP4540

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention