BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEX-D2 POSTERIOR FIXATION SYSTEM

    MDR report key: 19914118 · Received August 5, 2024

    Report

    Report Number
    3010020754-2024-00002
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    February 14, 2024
    Report Date
    August 5, 2024
    Manufacturer
    NEXT ORTHOSURGICAL
    Product Code
    LXH
    PMA / PMN Number
    K141291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCTION LOT RECORDS WERE REVIEWED AND THERE WERE NO ABNORMALITIES INDICATING MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS. THERE ARE NO TRENDS OR ADDITIONAL ADVERSE EVENTS FOR THIS PRODUCT TYPE OR SPECIFIC PRODUCTION LOT. AFTER A REVIEW OF THE REPORTED INFORMATION AND IMAGES OF THE REMAINDER OF THE DEVICE POST-EVENT, IT WAS DETERMINED THAT THE DEFORMATION OF THE INSTRUMENT SHOWN WOULD NOT HAVE OCCURRED WITH NORMAL USE. THE IMAGES SHOWED IRREGULAR DEFORMATION OF THE INSTRUMENT (NOT CLEAN BREAKAGE). THE INSTRUCTIONS FOR USE STATE THAT THE DEVICE SYSTEM SHOULD NOT BE USED WITH BONE CEMENT- WHICH WAS USED FOR THIS SURGICAL PROCEDURE. IT ALSO WARNS THAT DEVICE(S) CAN BREAK IF SUBJECTED TO EXCESSIVE FORCES GENERATED BY THE USER DURING INSERTION, FINAL POSITION, AND/OR REMOVAL. THE REPORT STATEMENT THAT THE BONE TAPPING WAS PERFORMED BEFORE THE CEMENT HARDENED FURTHER INDICATE THAT THE BONE TAP WAS IN THE SURGICAL AREA AS THE CEMENT WAS HARDENING. IF THE CEMENT HARDENED AS THE BONE TAP WAS BEING USED, IT WOULD GENERATE EXCESSIVE FORCE ON THE INSTRUMENT TIP PRIOR TO REMOVAL OF THE INSTRUMENT FROM THE AREA. A BONE TAP MANUFACTURED IN THE SAME TIME PERIOD AS THE REPORTED DEVICE THAT WAS RETAINED BY THE MANUFACTURER WAS TESTED AND THE ISSUE WAS NOT ABLE TO BE REPLICATED WITHOUT THE USE OF BONE CEMENT. THE FAILURE WAS CAUSED BY AN OVERAGE OF FORCE APPLIED ON THE INSTRUMENT TIP DUE TO UNAPPROVED USAGE WITH BONE CEMENT. BASED ON THE INVESTIGATION, THE ROOT CASUE HAS BEEN ATTRIBUTED TO A USER RELATED ISSUE. IF FURTHER INFORMATION IS PROVIDED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    THE REPORT PROVIDED STATED THAT THE TIP OF THE BONE TAP SURGICAL INSTRUMENT BROKE OFF COMPLETELY DURING SURGERY AND REMAINED IMPLANTED IN THE PATIENT. THE REPORT STATED THAT THIS OCCURRED WHILE THE SURGEON WAS USING THE INSTRUMENT TO TAP "AFTER INJECTING CEMENT WITH BKP (BALLOON KYPHOPLASTY) ON THE RIGHT SIDE OF L1. THE ORTHOPEDIC SURGEON DETERMINED THAT IT WAS DIFFICULT TO REMOVE THE BROKEN TIP FROM THE BONE CEMENT, SO THE FRAGMENT REMAINED IN THE BONE CEMENT. THE PEDICLE SCREW WAS NOT IMPLANTED INTO L1 BECAUSE OF THE FRAGMENT REMAINING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675499 NEX-D2 POSTERIOR FIXATION SYSTEM BONE TAP, MIS, 4.5MM LXH NEXT ORTHOSURGICAL CBZB005-45 0001217C1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Prefer Not To Disclose Other BONE CEMENT - MENDEC SPINE