BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRA SPINE SYSTEM

    MDR report key: 24720467 · Received March 30, 2026

    Report

    Report Number
    3004717358-2026-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 17, 2026
    Report Date
    March 27, 2026
    Manufacturer
    SPINECRAFT
    Product Code
    LXH
    UDI-DI
    00193082076480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR APPLICABLE MATERIAL, MANUFACTURING PROCESSES, DESIGN SPECIFICATIONS AND INSPECTION RECORDS. NO DEVIATIONS OR DISCREPANCIES WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. FURTHERMORE, THE USAGE HISTORY REVIEW SHOWED THIS LOT HAS BEEN IN USE IN VARIOUS SURGICAL STERILIZATION KITS FOR SEVERAL YEARS WITH NO SIMILAR COMPLAINTS REPORTED PREVIOUSLY. PER SPINECRAFT INSTRUCTION FOR USE, REUSABLE INSTRUMENTS ARE REQUIRED TO BE INSPECTED CAREFULLY PRIOR TO EACH SURGERY AND PARTICULARLY THE EDGES FOR THOSE INSTRUMENTS WITH CUTTING FEATURES MUST BE CHECKED FOR DISTORTION/LARGE NICKS. THAT SAID, BASED ON THE NATURE OF THE INCIDENT AND INFORMATION COLLECTED, WE CAN ONLY SPECULATE THAT THIS FAILURE IS A RESULT OF NORMAL WEAR AND TEAR.

    Description of Event or Problem · 0

    THE TIP OF THE Ø4.5MM TAP BROKE DURING USE. SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE TAP WITH NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782939 ASTRA SPINE SYSTEM BONE TAP LXH SPINECRAFT PM042714 00193082076480

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male