BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEO PEDICLE SCREW SYSTEM - ROD KIT PRE-BENT 40MM

    MDR report key: 21758861 · Received April 2, 2025

    Report

    Report Number
    3013546462-2025-00001
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    March 4, 2025
    Report Date
    April 3, 2025
    Manufacturer
    NEO MEDICAL SA
    Product Code
    NKB
    UDI-DI
    07640177820181
    PMA / PMN Number
    K212489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT DESCRIPTION: SET SCREW LOOSENING AND ROD SLIPPAGE (DISCONNECTION BETWEEN THE TULIP AND THE ROD) OCCURRED A FEW WEEKS POST OP (ORIGINAL POST OP ABOVE AND 3 WEEK POST OP BELOW) ON ONE SIDE OF A L2/L3 LLIF FUSION WITH POSTERIOR FIXATION. AFTER REVIEW, IT IS EXPECTED THAT THE ROD USED FOR THE SEGMENT WAS 5MM TOO SHORT. COMPLAINT INVESTIGATION: NEO MEDICAL GATHERED THE FOLLOWING INFORMATION BY INTERVIEWING SURGEONS AND SALES REP: "A TOO SHORT ROD WAS USED". THIS TYPE OF ISSUE IS KNOWN AND DISPLAYED IN THE SURGICAL TECHNIQE WITH A FEW MM OVERHANG IS DESCRIBED. BY ANALYSING THE MRI AND X-RAYS IMAGES WE CAN CONCLUDE THAT FROM MEASURING THE OVERHANG A 0.5MM DIFFERENCE ON ONE SIDE OF THE ROD CAUSED ONE SIDE TO SLIP (1.5MM OVERHANG) WHILE THE OTHER SIDE DID NOT (2.0 MM OVERHANG). NEO MEDICAL ALSO LOOKED AT THE BATCH PRODUCTION RECORDS FOR THE AFFECTED LOTS, THE REPORT CONCLUDED NO RELEVANT DEVIATIONS RELATED TO PRODUCT QUALITY. THE MOST PROBABLE ROOT CAUSE OF THE FAILURE WAS THAT THE ROD USED WAS TOO SHORT RESULTING DUE TO A LACK OF CONTACT POINT BETWEEN ROD AND SCREW HEAD ("THE TULIP") RESULTING IN A DISCONNECTION OF THE CONSTRUCT. THIS IS THE FIRST TIME THAT A TOO SHORT ROD HAVE BEEN USED IN SURGERY, WITH MORE THAN 26000 SURGERIES PERFORMED TO DATE, IT GIVES AN OCCURENCE OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458474 NEO PEDICLE SCREW SYSTEM - ROD KIT PRE-BENT 40MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NEO MEDICAL SA ROD KIT PRE-BENT 40MM 2021041973 07640177820181

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention SC-70-45-PE