BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXIS

    MDR report key: 22883708 · Received August 25, 2025

    Report

    Report Number
    3010673777-2025-00002
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 22, 2025
    Manufacturer
    NOVATEP SAS - RENNES - FRANCE
    Product Code
    HWC
    UDI-DI
    03700879501215
    PMA / PMN Number
    K143229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE FIRST IMPLANTATION, THE FRAGMENT WAS DETECTED ON XRAYS IMAGING AND WAS INTENTIONALLY LEFT IN SIDE. AFTER ITS SUBSEQUENT REMOVAL OF THE FRAGMENT, NO CORRECTIVE PROCEDURE WAS UNDERTAKEN TO REPOSITION THE SCREW.

    Description of Event or Problem · 0

    INITIAL INFORMATION: ANSM (FRENCH COMPETENT AUTHORITY) REPORT FROM THE USER INDICATING A BROKEN SCREW. ADDITIONAL INFORMATION ON AUGUST 6TH: DURING IMPLANTATION IN FEBRUARY, SLIGHT METAL FILINGS CAME LOOSE FROM THE DISTAL THREAD OF THE SCREW. THIS PART REMAINED IN THE SOFT TISSUE SURROUNDING THE BONE. FOUR MONTHS LATER, AS THE PATIENT EXPERIENCED PAIN AND DISCOMFORT, X-RAYS WERE PERFORMED, SHOWING THAT THE FRAGMENT HAD MIGRATED IN THE SOFT TISSUE. THE SURGEON DECIDED TO RE-OPEN THE PATIENT SO AS TO REMOVE THE THREAD. THIS CORRECTION SURGERY WAS PERFORMED ON (B)(6), 2025. THE XRAYS SHOW A DEEP INSERTION OF THE SCREW, SO MUCH THAT IT SEEMS TO PROTRUDE AT LEAST 3MM FROM THE BONE. NB: INCIDENT REPORTED TO ANSM BY THE USER. REF # (B)(4). A SECOND REPORT HAS BEEN ADDRESSED TO ANSM BY THE USER: # (B)(6). IT MENTIONS THE SECOND SCREW USED AT THE SAME TIME BUT IT TURNED OUT TO BE IRRELEVANT AS THIS SECOND SCREW WASN'T PROBLEMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292231 NEXIS COMPRESSIVE SCREW Ø2.9 LG32 HWC NOVATEP SAS - RENNES - FRANCE SC020032 L01805 03700879501215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other