BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEX-D2 POSTERIOR FIXATION SYSTEM, VARIABLE CROSS LINK (40-56 MM)

    MDR report key: 24119159 · Received January 20, 2026

    Report

    Report Number
    3010020754-2026-00002
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    May 29, 2024
    Report Date
    January 20, 2026
    Manufacturer
    NEXT ORTHOSURGICAL
    Product Code
    NKB
    UDI-DI
    00840314120366
    PMA / PMN Number
    K161499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NEXT ORTHOSURGICAL INC. CONDUCTED A COMPLAINT INVESTIGATION FOR THE REPORTED MALFUNCTION INVOLVING A VARIABLE CROSS LINK (40-56 MM), MODEL CBEAJ-55040, LOT U006308B, A COMPONENT OF THE NEX-D2 POSTERIOR FIXATION SYSTEM. THE MANUFACTURER BECAME AWARE OF THE EVENT ON JUNE 3, 2024. THE COMPLAINT REPORTED THAT DURING A RE-OPERATION PERFORMED ON (B)(6) 2024, THE CROSS-LINK BEAM FRACTURED AT THE BASE OF THE GRIPPING SECTION, AND THE HOOKED/GRASPING PORTION COULD NOT BE REMOVED FROM THE SPINAL ROD AFTER THE SET SCREW WAS REMOVED. THE SURGICAL PROCEDURE WAS COMPLETED WITH THE GRIPPING PORTION REMAINING IN SITU. THE PATIENT RECOVERED, AND NO DEATH, LIFE-THREATENING CONDITION, OR PERMANENT IMPAIRMENT WAS REPORTED. THE INVESTIGATION INCLUDED REVIEW OF THE DEVICE HISTORY RECORD, WHICH CONFIRMED THAT THE DEVICE MET APPLICABLE INSPECTION AND RELEASE CRITERIA. AN EXISTING NONCONFORMING MATERIAL RECORD RELATED TO INCORRECT SIZE/LASER MARKING WAS IDENTIFIED; HOWEVER, THIS NONCONFORMANCE WAS DETERMINED NOT TO BE RELATED TO THE REPORTED FRACTURE FAILURE MODE. EVALUATION OF THE RETURNED DEVICE CONFIRMED FRACTURE OF THE CROSS-LINK BEAM AT THE BASE OF THE GRIPPING SECTION. FRACTURE SURFACE CHARACTERISTICS WERE CONSISTENT WITH LONG-TERM MECHANICAL FATIGUE AND STRESS CONCENTRATION ASSOCIATED WITH EXTENDED IN VIVO USE (APPROXIMATELY FIVE YEARS). NO EVIDENCE WAS IDENTIFIED THAT THE FRACTURE WAS CAUSED BY A MANUFACTURING PROCESS DEVIATION, DESIGN INADEQUACY, LABELING DEFICIENCY, OR USER ERROR. HISTORICAL COMPLAINT DATA AND TREND ANALYSIS DID NOT IDENTIFY AN INCREASE IN SIMILAR EVENTS. BASED ON THE INVESTIGATION, THE EVENT WAS CONCLUDED TO BE A COMPONENT-LEVEL MECHANICAL FAILURE OCCURRING OVER EXTENDED IMPLANT DURATION, CONSISTENT WITH KNOWN AND DOCUMENTED DEVICE RISKS. NO CORRECTIVE OR PREVENTIVE ACTION WAS DEEMED NECESSARY AT THIS TIME. THIS EVENT IS BEING REPORTED AS A DEVICE MALFUNCTION, AS RECURRENCE OF A SIMILAR FAILURE COULD POTENTIALLY RESULT IN PATIENT INJURY, ALTHOUGH NO INJURY OCCURRED IN THIS CASE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, DURING A RE-OPERATION ON A PATIENT WHO PREVIOUSLY UNDERWENT L3-L5 SPINAL FIXATION IN 2019, A VARIABLE CROSS LINK (40-56 MM) WAS REMOVED. DURING REMOVAL, THE CROSS-LINK BEAM FRACTURED, AND THE HOOKED/GRASPING END OF THE BEAM COULD NOT BE REMOVED FROM THE SPINAL ROD, EVEN AFTER THE CROSS-LINK SET SCREW WAS REMOVED. AS A RESULT, THE SURGICAL PROCEDURE WAS COMPLETED WITH THE GRASPING PORTION OF THE DEVICE REMAINING IN SITU. THE PATIENT RECOVERED, AND NO DEATH, LIFE-THREATENING CONDITION, OR PERMANENT IMPAIRMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178290 NEX-D2 POSTERIOR FIXATION SYSTEM, VARIABLE CROSS LINK (40-56 MM) THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NEXT ORTHOSURGICAL CBEAJ-55040 U006308B 00840314120366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other