BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBS S SNAPP OFF SCREW

    MDR report key: 24245005 · Received February 3, 2026

    Report

    Report Number
    3010470577-2025-10301
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    October 17, 2025
    Report Date
    November 24, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HWC
    PMA / PMN Number
    K191380
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    CONMED NOTIFIED IN2BONES SAS ON OCTOBER 23, 2025 WITH A COMPLAINT DESCRIBING THE FOLLOWING EVENT: "IT WAS REPORTED ON (B)(6) 2025 THAT AN EXPIRED IBS SNAP-OFF SCREW WAS IMPLANTED INTO A PATIENT ON (B)(6) 2025 AT (B)(6) CENTER". COMPLAINANT: (B)(4). PRODUCT REFERENCE: S22 ST014. LOT : 2003088.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304969 IBS S SNAPP OFF SCREW Screw, fixation, bone HWC IN2BONES SAS 2003088

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other