BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AESCULAP

    MDR report key: 24808847 · Received April 7, 2026

    Report

    Report Number
    2916714-2026-00013
    Event Type
    Injury
    Date Received
    April 7, 2026
    Report Date
    April 7, 2026
    Manufacturer
    AESCULAP INC.
    Product Code
    EJY
    UDI-DI
    04046964683978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FILED UNDER AIC REFERENCE: (B)(4). INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT, DURING A REVISION POSTERIOR THORACIC SPINE FUSION PROCEDURE, A LARGE HAND-HELD ROD CUTTER WAS USED TO CUT A COBALT CHROME ROD. WHILE CUTTING, THE INSTRUMENT SHATTERED UNEXPECTEDLY. MULTIPLE COMPONENTS OF THE DEVICE, INCLUDING SCREWS, PLATES, AND/OR HINGE ELEMENTS, BECAME DISLODGED AND WERE SCATTERED WITHIN THE SURGICAL FIELD. THE SURGICAL FIELD WAS INSPECTED, AND ALL FRAGMENTS WERE RETRIEVED. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537113 AESCULAP PLIERS, OPERATIVE EJY AESCULAP INC. MG090R 04046964683978

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown