BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTROLOCK

    MDR report key: 23932540 · Received December 31, 2025

    Report

    Report Number
    3010673777-2025-00041
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    October 27, 2025
    Report Date
    December 31, 2025
    Manufacturer
    NOVASTEP SAS
    Product Code
    HRS
    UDI-DI
    03700879511849
    PMA / PMN Number
    K192356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN SUMMARY, THE IMPLEMENTATION OF THE DEVICE TOOK PLACE ON (B)(6) 2025, IN FRANCE. AFTER SIX MONTHS, ON (B)(6) 2025, A POTENTIAL DEVICE ISSUE WAS SUSPECTED. THIS ISSUE WAS CONFIRMED ON (B)(6) 2025, THROUGH X-RAY IMAGING. WE RECEIVED THIS INFORMATION ON NOVEMBER 25, 2025. THE SURGEON REPORTED THAT THE HEALING PROCESS IS PROGRESSING APPROPRIATELY AND PLANS TO CONTINUE MONITORING THE PATIENT THROUGHOUT 2026. ADDITIONNAL INVESTIGATION MAY BE CONCIDERED ON SIMILAR DEVICES, IN CASE OF EXPLANTATION ON THE CONSENT DEVICE ITSELF.

    Description of Event or Problem · 0

    THIS EVENT TOOK PLACE IN FRANCE, NOVASTEP HAVE BEEN INFORMED OF THIS CASE ON THE 11/25/2025. BREAKAGE OF THE IMPLANT POST OP. DEVICE IMPLANTED ON (B)(6) 2025. AT 6 MONTHS POST IMPLANTATION, ON (B)(6) 2025, A DEVICE PROBLEM WAS SUSPECTED DURING A SCANNER PERFORMED AS THE PATIENT REPORTED UNUSUAL PAIN. THE PROBLEM WAS CONFIRMED ON (B)(6) 2025 BY PERFORMING X-RAYS. IT REVEALS THAT THE IMPLANT HAS BROKEN. CONSEQUENCE: AS REPORTED BY THE SURGEON "AS FAR AS TREATMENT IS CONCERNED, IT REMAINS RELATIVELY PAINLESS FOR THE MOMENT AND BONE CALLUS IS GRADUALLY FORMING AT THE OSTEOTOMY SITE WITH GOOD CORRECTION OF THE FOOT." THE SURGEON HAS THEREFORE AUTHORIZED HER TO GRADUALLY RESUME WEARING NORMAL SHOES WITH RIGID SOLES. HE PLANS TO MONITOR THE PATIENT IN (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2707083 CENTROLOCK IMPLANT CENTROLOCK LEFT STEP 4 HRS NOVASTEP SAS K03252 03700879511849

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other