BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM

    MDR report key: 23183495 · Received September 30, 2025

    Report

    Report Number
    3006179046-2025-00123
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    August 28, 2025
    Report Date
    January 20, 2026
    Manufacturer
    NUVASIVE, INC.
    Product Code
    HSB
    UDI-DI
    00812258020279
    PMA / PMN Number
    K220234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE NAIL WAS RECEIVED AT GLOBUS MEDICAL AND UNDERWENT A VISUAL INSPECTION WHERE NO VISIBLE DEFECTS WERE FOUND. THE NAIL WAS RECEIVED AT A LENGTH OF 350.19MM, SHOWING THE NAIL WAS ABLE TO DISTRACT PRIOR TO BEING RETURNED TO GLOBUS. X-RAYS OF THE NAIL WERE TAKEN WITH NO DISCREPANCIES FOUND WITH ANY OF THE INTERNAL COMPONENTS. THE DHR FOR THE LOT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ALL 17 NAILS IN THE LOT PASSED FUNCTIONAL ACCEPTANCE TESTING AND QUALITY INSPECTION. PRODUCTION X-RAYS WERE REVIEWED FOR THE RELEASED NAILS WITH NO DISCREPANCIES OR ABNORMALITIES NOTED. THE COMPLAINT ALLEGED THAT THE NAIL WAS UNABLE TO DISTRACT AT A 1MM:1MM RATIO WITH THE ERC, BUT THE CONTRALATERAL NAIL IN THE LEFT FEMUR WAS DISTRACTING AT A 1MM:1MM RATIO WITH THE ERC. AN IN-HOUSE ERC1 WAS PROGRAMMED TO DISTRACT THE NAIL 2MM. AFTER THE DISTRACTION SESSION, THE NAIL MEASURED 352.11MM FOR A DISTRACTION LENGTH OF 1.92MM. THIS IS WITHIN AN ERC'S DISTRACTION ACCURACY SPECIFICATION OF ±10% + ±0.30MM, WHICH FOR A 2MM DISTRACTION WOULD BE 2MM ±0.5MM. THE NAIL WAS ABLE TO FULLY DISTRACT AND RETRACT WITH THE USE OF THE STROKE TEST FIXTURE, AND IT WAS ALSO ABLE TO GENERATE THE REQUIRED MINIMUM 180LBS OF FORCE NEEDED FOR PRODUCTION RELEASE TESTING. THE NAIL WAS CUT OPEN WITH THE USE OF A LATHE FOR A FINAL VISUAL CHECK ON THE INTERNAL COMPONENTS, BUT NO DISCREPANCIES OR ABNORMALITIES WERE FOUND. THESE TESTS SUGGEST THAT THE NAIL IS FUNCTIONING ACCORDING TO ITS SPECIFICATIONS AND THE COMPLAINT IS UNABLE TO BE CONFIRMED. THE ASSOCIATED RISK DOCUMENT WAS REVIEWED, AND THE FAILURE MODE, EFFECTS, AND HARMS POTENTIALLY RELATED TO THE EVENT HAVE BEEN IDENTIFIED AND MITIGATED. FURTHERMORE, THE COMPLAINT RATE IS WITHIN THE ESTIMATED RATE IN THE RISK DOCUMENTATION ASSOCIATED WITH THIS PRODUCT. BASED ON THIS RISK ASSESSMENT, NO NEW OR ADDITIONAL RISK EVALUATION IS NECESSARY. COMPLAINT MONITORING WILL CONTINUE AND ADDITIONAL ACTION WILL BE TAKEN IN THE EVENT THAT AN ADVERSE TREND IS IDENTIFIED. NO ADDITIONAL ACTION IS PLANNED AT THIS TIME.

    Description of Event or Problem · 0

    IMPLANTED PRECISE NAIL BROKEN, REVISION PROCEDURE COMPLETED TO REMOVE AND REPLACE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN IMPLANTED PRECICE NAIL BROKEN, REVISION PROCEDURE COMPLETED TO REMOVE AND REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014056 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE, INC. P10.7-80B305 GB1607VAC 00812258020279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown