BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE TAP MIS 4.5

    MDR report key: 24222175 · Received January 30, 2026

    Report

    Report Number
    3010020754-2026-00003
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    July 31, 2025
    Report Date
    January 29, 2026
    Manufacturer
    NEXT ORTHOSURGICAL
    Product Code
    LXH
    UDI-DI
    00840314121103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, DURING A LUMBAR SPINE SURGICAL PROCEDURE PERFORMED AT (B)(6) HOSPITAL IN (B)(6), A BONE TAP, MIS 4.5 (CATALOG NUMBER CBZB005-45, LOT NUMBER 002156D13), MANUFACTURED BY NEXT ORTHOSURGICAL INC., WAS USED TO PREPARE BONE FOR PEDICLE SCREW INSERTION. DURING THE PROCEDURE, THE SURGEON INITIALLY USED A 5.0 MM BONE TAP; HOWEVER, BONE MATERIAL BECAME LODGED IN THE TAP, PREVENTING GUIDE WIRE PASSAGE. THE SURGICAL PLAN WAS ADJUSTED TO PERFORM SEQUENTIAL TAPPING USING A 4.5 MM BONE TAP FOLLOWED BY A 6.5 MM TAP PRIOR TO INSERTION OF A 7.0 MM SCREW. WHILE TAPPING AT THE L5 VERTEBRAL LEVEL USING THE 4.5 MM BONE TAP, THE DEVICE FRACTURED INTRAOPERATIVELY, RESULTING IN SEPARATION OF THE DISTAL TIP, WHICH REMAINED RETAINED WITHIN THE BONE. THE FRAGMENT COULD NOT BE REMOVED DURING THE PROCEDURE. NO PATIENT INJURY, ADVERSE CLINICAL OUTCOME, OR MEDICAL INTERVENTION RELATED TO DEVICE-CAUSED HARM WAS REPORTED. THE COMPLAINT RECORD INDICATES THAT THERE HAVE BEEN NO REPORTED PROBLEMS WITH THE PATIENT SINCE THE SURGERY. THE DEVICE INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN OR PHYSICAL EVALUATION, AS THE FRACTURED FRAGMENT REMAINED RETAINED IN THE PATIENT AND NO DEVICE SAMPLE WAS RETURNED TO THE MANUFACTURER. AS PART OF THE INVESTIGATION, THE MANUFACTURER REVIEWED THE DEVICE HISTORY RECORD (DHR) FOR THE AFFECTED LOT AND CONFIRMED THAT THE DEVICE MET ALL INSPECTION AND RELEASE CRITERIA. NO MANUFACTURING NONCONFORMANCES WERE IDENTIFIED. THE INVESTIGATION ALSO INCLUDED REVIEW OF IMAGES PROVIDED BY THE USER FACILITY AND COMPARISON WITH A PRIOR SIMILAR COMPLAINT INVOLVING THE SAME PRODUCT AND LOT, WHICH DEMONSTRATED SIMILAR FRACTURE CHARACTERISTICS. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION CONCLUDED THAT THE FRACTURE LIKELY OCCURRED DUE TO EXTERNAL FORCES APPLIED DURING USE, WITH NO EVIDENCE OF A DEVICE DESIGN OR MANUFACTURING DEFECT. THIS EVENT IS REPORTED AS A DEVICE MALFUNCTION, AS RECURRENCE OF THE FRACTURE COULD REASONABLY CAUSE OR CONTRIBUTE TO SERIOUS INJURY, IN ACCORDANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 0

    DURING LUMBAR SPINE SURGERY, A BONE TAP MIS 4.5 MM FRACTURED DURING NORMAL USE. THE DISTAL TIP OF THE BONE TAP REMAINED RETAINED WITHIN THE PATIENT'S BONE AND COULD NOT BE RETRIEVED INTRAOPERATIVELY. NO PATIENT INJURY, ADVERSE CLINICAL OUTCOME, OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION RELATED TO HARM WAS REPORTED. THE DEVICE DID NOT PERFORM AS INTENDED. THE EVENT IS CONSIDERED A DEVICE MALFUNCTION WITH POTENTIAL FOR SERIOUS INJURY IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282685 BONE TAP MIS 4.5 TAP, BONE LXH NEXT ORTHOSURGICAL CBZB005-45 002156D13 00840314121103

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Other