BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR

    MDR report key: 9755013 · Received February 26, 2020

    Report

    Report Number
    3005180920-2020-00091
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    January 27, 2020
    Report Date
    February 26, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971235847
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 FEBRUARY 2019: LOT 1857766: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE NO ANY SIMILAR EVENT REPORTED. OTHER DEVICE INVOLVED: MYSPINE 7.0724 MYSPINE MC DRILL BASED GUIDE L04 (K173472) BATCH REVIEW PERFORMED ON 07 FEBRUARY 2020: LOT 02633S: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM.

    Description of Event or Problem · 1

    DURING THE PRIMARY SPINE SURGERY, WHILE THE SURGEON WAS PERFORMING L4/5 POSTERIOR LUMBER FUSION, AND WHEN PLACING BOTH THE L4/5 GUIDES, THE SURGEON HAD PLANNED TO PLACE 45MM SCREWS IN L4 AND 40 MM SCREWS IN L5 DUE TO THE TRAJECTORY FROM THE DRILLS HE WAS ONLY ABLE TO PLACE 35 MM SCREWS. IN ADDITION, WHEN THE SURGEON WENT TO CHECK AP FLUOROSCOPY PLACEMENT OF THE L4 RIGHT SIDED PEDICLE HE NOTICED A MEDIAL BREAK OF THE PEDICLE. THE SURGEON HAD DRILLED AND PLACED PEDICLE MARKERS, WHEN THIS WAS FOUND. AFTER PERFORMING HIS DECOMPRESSION, HE WENT BACK AND REVISED THE L4 SCREW TRAJECTORY WITH A FREE HAND APPROACH. THE TOTAL DELAY WITH THE GUIDES AND REPLACEMENT OF THE L4 SCREW WAS 20 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220955 MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR SPINE INSTRUMENT LXH MEDACTA INTERNATIONAL SA 1857766 07630971235847

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R