BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INBONE ML PLATE

    MDR report key: 23840512 · Received December 18, 2025

    Report

    Report Number
    3010667733-2025-01540
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 25, 2025
    Report Date
    February 17, 2026
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    LXH
    UDI-DI
    00889797047944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE RETURNED DEVICE IS CONFORMING TO SPECIFICATIONS AND FULLY FUNCTIONAL. THE DEVICE INSPECTION REVEALED THE FOLLOWING: VISUAL EXAMINATION OF THE RETURNED ML PLATE SHOWS THE DEVICE IS IN GOOD CONDITION WITH NO SIGNS OF DAMAGE OR DEFORMATION. THE ML PLATE WAS RECEIVED WITH ONE SCREW PRESENT AND PROPERLY INSTALLED IN THE DESIGNATED SLOT AS INTENDED BY THE DEVICE DESIGN. GQO REVIEWED THE RECEIVED INFORMATION AND NOTED THE FOLLOWING: DURING REVIEW OF THE PRINT AND MODEL ON PART NUMBER IB100094, THERE IS ONLY ONE SCREW REQUIRED FOR THIS PART. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT " THE ITEM UNDER PO (B)(4) WAS RECEIVED WITHOUT THE SCREWS. THE PACKAGING SHOWED NO DAMAGE. THIS IS AN OUT OF BOX FAILURE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE ITEM UNDER (B)(4) WAS RECEIVED WITHOUT THE SCREWS. THE PACKAGING SHOWED NO DAMAGE. THIS IS AN OUT OF BOX FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257651 INBONE ML PLATE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHT MEDICAL TECHNOLOGY INC 3251864 00889797047944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown