BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELINE

    MDR report key: 23993957 · Received January 7, 2026

    Report

    Report Number
    2031966-2026-00008
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 2, 2025
    Report Date
    March 30, 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 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED A COMPLAINT REPORT WHERE THE TIP OF THE RELINE-O FINAL LOCK SCREWDRIVER BROKE WHILE THE CLOSING PROCESS WITH THE TORQUE. IT WAS REPORTED THAT THE TORQUE WAS TESTED AND FAILED. THE TIP STAYED INSIDE THE LOCK SCREW, NO OPTION TO REMOVE IT, BUT NO IMPACT TO THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO ASSOCIATED TORQUE HANDLE INFORMATION WAS PROVIDED; THE INVOLVED DEVICES COULD NOT BE ACQUIRED FOR REVIEW. ALTHOUGH NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, REVIEW OF THE REPORTED EVENT AND SIMILAR EVENTS SUGGESTS EXCESSIVE FORCE, EXCESSIVE TORQUE AND/OR FATIGUE AS THE LIKELY CAUSE OR CONTRIBUTORS. THE FRACTURED TIP PER SURGEON¿S PREROGATIVE WAS LEFT IN-SITU AND THE STAINLESS-STEEL MATERIALS THAT WERE UNRETRIEVED IN THIS EVENT CAN BE CONSIDERED TO EXERT VERY LOW TOXICITY POTENTIAL AND TO POSE NEGLIGIBLE RISK TO THE PATIENT. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. A MANUFACTURING REVIEW WAS COMPLETED. REVIEW OF THE DEVICE HISTORY RECORDS OF ALL DEVICES NOTES THE DEVICE RELEASED MARCH 2021, UNDER CONSIGNMENT USE FOR OVER FOUR (4) YEARS. ADDITIONALLY, NO MATERIAL NON-CONFORMANCE, 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. A LABELING REVIEW AND LITERATURE REVIEW WERE COMPLETED. REVIEW OF BIOCOMPATIBILITY OF STAINLESS STEEL FOR USE IN NUVASIVE, INC. MEDICAL INSTRUMENTS FINAL REPORT 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. A RISK EVALUATION WAS COMPLETED. REVIEW OF THE COMPLAINT AND ASSOCIATED RISK DOCUMENT (B)(4) LINES RM-20, RM-240, D90, D100, D110 AND U110 FOUND THE EFFECTS POTENTIALLY RELATED TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AND MITIGATED AND THE SEVERITY OF POSSIBLE EFFECTS DO NOT EXCEED THOSE ESTIMATED IN THE RISK DOCUMENTATION. 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. THIS PRODUCT IS WITHIN THE ANTICIPATED RISK; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF A RELINE-O FINAL LOCK SCREW DRIVER BROKE DURING THE CLOSING PROCESS WITH THE TORQUE. THE TORQUE WAS TESTED AND FAILED. THE TIP STAYED INSIDE THE LOCK SCREW, NO OPTION TO REMOVE IT, BUT NO IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE RELINE O FINAL LOCK SCREW DRIVER BROKE DURING THE CLOSING PROCESS WITH THE TORQUE. TORQUE WAS TESTED AND FAILED. 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
    49597 RELINE SURGICAL SCREWDRIVER, REUSABLE LXH NUVASIVE, INC. 10000751 NM3844 00887517513724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown