BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTROLOCK

    MDR report key: 23704253 · Received December 3, 2025

    Report

    Report Number
    3010673777-2025-00004
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    July 1, 2025
    Report Date
    December 3, 2025
    Manufacturer
    NOVASTEP SAS
    Product Code
    HRS
    UDI-DI
    03700879511870
    PMA / PMN Number
    K192356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRACTICIAN DID NOT REPORT ANY DIFFICULTY DURING THE SURGERY, AND DID NOT MENTION ANY INADEQUATE BEHAVIOR OF THE PATIENT DURING RECOVERY. THE PRACTICIAN DECIDED TO WAIT 6 MONTHS TO ALLOW BONE HEALING, DESPITE THE PAIN EXPERIENCED LOCALLY BY THE PATIENT. DURING REMOVAL PERFORMED ON (B)(6) 2025, THE PRACTICIAN CONFIRMED THE NEED TO REPLACE THE IMPLANT TO ALLOW CORRECT BONE HEALING. 2 SCREWS HAVE BEEN USED TO THIS VIEW. MANUFACTURER INVESTIGATION: BATCH RECORD REVIEWED: NO ROOT CAUSE IDENTIFIED FROM THE MANUFACTURING PROCESS. INSPECTION OF 3 PARTS FROM THE SAME BATCH: THE PRODUCTS ARE FULLY COMPLIANT TO THE MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    DATE OF MANUFACTURER AWARENESS OF THIS DEFECT IS THE 11/05/2025. DURING THE FOLLOW-UP X-RAY AT T+13 WEEKS AFTER IMPLANTATION, THE SURGEON OBSERVED THAT THE IMPLANT HAS BROKEN SINCE ITS IMPLANTATION. CASE: TRANSVERSE OSTEOTOMY FOR BUNION CORRECTION. THE SURGEON DECIDED TO MAINTAIN THE IMPLANTS IN THE PATIENT AS THE BONE HEALING WAS GOING ON. ON THE 5TH OF NOVEMBER 2025, THE SURGEON INFORMED US THAT THE PATIENT WAS EXPERIENCING PAIN, AND THAT IT REQUIRES A NEW SURGERY IN ORDER TO REMOVE THE IMPLANT AND, IF THE BONE UNINON IS NOT SATISFYING, TO REPLACE BY ANOTHER IMPLANT AS TO STABILIZE IT. EXPLANTATION PREFORMED ON THE (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24559 CENTROLOCK IMPLANT CENTROLOCK DROIT STEP 4 HRS NOVASTEP SAS PL070104 L20966 03700879511870

    Patients

    Seq Age Sex Outcome Treatment
    1