BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELINE

    MDR report key: 23871301 · Received December 22, 2025

    Report

    Report Number
    2031966-2025-00169
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 4, 2025
    Report Date
    April 22, 2026
    Manufacturer
    NUVASIVE, INC.
    Product Code
    LXH
    UDI-DI
    00887517513724
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED A COMPLAINT THAT REPORTED THE TIP OF A RELINE-O FINAL LOCK SCREW DRIVER BROKE DURING THE CLOSING PROCESS WITH THE TORQUE. TORQUE WAS TESTED AND TEST WAS SUCCESSFUL. THE TIP STAYED INSIDE THE LOCK SCREW, NO OPTION TO REMOVE IT, BUT NO IMPACT TO THE PATIENT. NO PRODUCT WAS RETURNED FOR INVESTIGATION, AND NO PHOTOGRAPHS OF THE INSTRUMENT WERE PROVIDED FOR REVIEW EITHER. THE REP WAS CONTACTED BUT DID NOT RESPOND AT THE TIME OF THE EVALUATION. AS A RESULT, THE COMPLAINT WAS UNABLE TO BE CONFIRMED WITH THE INFORMATION PROVIDED. A REVIEW OF THE REPORTED EVENT, AS WELL AS SIMILAR REPORTED EVENTS INDICATE POSSIBLE CAUSES OF FAILURE TO BE WEAR DUE TO CONTINUOUS USE OVER TIME, EXCESSIVE FORCES AND/OR EXCESSIVE TORQUE APPLIED TO THE INSTRUMENT. IT WAS REPORTED THAT THE FRACTURED INSTRUMENT TIP REMAINED IN-SITU PER THE SURGEON'S PREROGATIVE. STAINLESS-STEEL MATERIALS THAT WERE UNRETRIEVED IN THIS EVENT CAN BE CONSIDERED TO EXERT VERY LOW TOXICITY POTENTIAL AND POSE NEGLIGIBLE RISK TO THE PATIENT. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. MANUFACTURING REVIEW OF THE DEVICE HISTORY RECORDS NOTES NO MATERIAL NON-CONFORMANCE'S, NO MANUFACTURING ERRORS, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, DIMENSIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE. LABELING AND LITERATURE REVIEW WERE COMPLETED. REVIEW OF BIOCOMPATIBILITY OF STAINLESS STEEL FOR USE IN NUVASIVE, INC. MEDICAL INSTRUMENTS HAS PROVIDED SUFFICIENT SUPPORTING DOCUMENTATION FOR THE STAINLESS-STEEL TYPE 17-4, STAINLESS STEEL TYPE 455, STAINLESS STEEL TYPE 465, AND STAINLESS-STEEL TYPE 316 USED IN THE NUVASIVE, INC. MEDICAL SURGICAL INSTRUMENTS AT LOCATIONS OF POTENTIAL INSTRUMENT FAILURE TO BE CONSIDERED BIOCOMPATIBLE. THE POTENTIAL LONG-TERM EXPOSURE OF LODGED OR EMBEDDED STAINLESS STEEL MATERIAL IN THE EVENT OF INSTRUMENT FAILURE WAS REVIEWED. THE AFOREMENTIONED MATERIALS WERE DETERMINED TO POSSESS A CHROMIUM OXIDE PASSIVATION LAYER WHICH SERVES TO CREATE A MATERIAL WITH NEGLIGIBLE POTENTIAL FOR LEACHABLE METALLIC ELEMENTS AND VIRTUALLY NO POTENTIAL FOR MATERIAL-INDUCED TOXICITY. THEREFORE, IN SITUATIONS WHERE THE PHYSICIAN HAS DETERMINED THAT REMOVAL OF THE INSTRUMENT FRAGMENT IS NOT POSSIBLE AND THE ONLY SAFE OPTION IS LEAVING IT EMBEDDED IN THE PATIENT, THESE STAINLESS-STEEL MATERIALS CAN BE CONSIDERED TO EXERT VERY LOW TOXICITY POTENTIAL AND TO POSE NEGLIGIBLE RISK TO THE PATIENT. RISK EVALUATION WAS COMPLETED. REVIEW OF THE COMPLAINT AND ASSOCIATED RISK FOUND THE EFFECTS POTENTIALLY RELATED TO THE REPORTED EVENT HAVE BEEN MITIGATED AND THE SEVERITY OF POSSIBLE EFFECTS DO NOT EXCEED THOSE ESTIMATED IN THE RISK DOCUMENTATION. THERE IS NO NEW HARM EVENT OR ADVERSE TREND IDENTIFIED WITH THE REPORTED EVENT. ADDITIONALLY, BASED ON THE RISK LEVEL ESTIMATED FOR THIS PRODUCT, THIS COMPLAINT DOES NOT JUSTIFY THE NEED FOR NEW OR ADDITIONAL RISK EVALUATION.

    Additional Manufacturer Narrative · 0

    THE TIP OF THE DEVICE REMAINS EMBEDDED IN THE LOCKSCREW. THE REMAINDER OF THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE TIP BROKE WHILE THE CLOSING PROCESS WITH THE TORQUE. TORQUE WAS TESTED AND TEST WAS SUCCESSFUL. THE TIP STAYED INSIDE THE LOCK SCREW, NO OPTION TO REMOVE IT, BUT NO IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    THE TIP BROKE WHILE THE CLOSING PROCESS WITH THE TORQUE. TORQUE WAS TESTED AND TEST WAS SUCCESSFUL. THE TIP STAYED INSIDE THE LOCK SCREW, NO OPTION TO REMOVE IT, BUT NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11164 RELINE SURGICAL SCREWDRIVER, REUSABLE LXH NUVASIVE, INC. 10000751 NM3856 00887517513724

    Patients

    Seq Age Sex Outcome Treatment
    1