BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 23528612 · Received November 11, 2025

    Report

    Report Number
    3007593722-2025-00018
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 11, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    LXH
    UDI-DI
    M97029002402500
    PMA / PMN Number
    D151231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS OPENED FOR A REPORT OF A REVISION SURGERY TO REMOVE A DYNANAIL MINI CONNECTION SCREW AFTER PATIENT REPORTED PAIN. PER THE REPORTER, THE DYNANAIL MINI WAS IMPLANTED APPROXIMATELY TWO YEARS PRIOR; THE PATIENT PRESENTED HEEL PAIN AND AFTER BOTH AN X-RAY AND MRI REVEALED NOTHING CONCLUSIVE TO BE CAUSING PAIN, THE PHYSICIAN CHOSE TO REMOVE THE IMPLANT TO SEE IF THE PAIN WOULD SUBSIDE. THE REPORTER STATED THAT THERE WAS NOTHING WRONG OR ANY MALFUNCTIONS FROM THE DEVICE AND SCREWS. THE SAMPLE WAS DISCARDED AT THE FACILITY. THE DYNANAIL MINI RISK MATRIX WAS REVIEWED AND IN IT, THE FAILURE MODE OF ANY OF THE IMPLANTABLE COMPONENTS (SCREWS, NAIL BODY AND COMPRESSIVE OR SLIDING ELEMENT) NOT BEING BIOCOMPATIBLE IS RECORDED AND ACCOUNTED FOR WHERE IN THE POTENTIAL CAUSE FOR THE FAILURE IS THAT THE BIOCOMPATIBILITY IS NOT CONFIRMED. THIS IS RANKED WITH A DETECTION SCORE OF 1, PATIENT SEVERITY OF 4, DEVICE SEVERITY OF 1 AND OCCURRENCE OF 1. WHILE THE BIOCOMPATIBILITY OF THE DEVICE CAUSING THE ADVERSE PATIENT REACTION IS A POSSIBLE CAUSE, IT CANNOT BE CONFIRMED AND THE PROBABLE ROOT CAUSE FOR THE PAIN LEADING TO REMOVAL. OTHER POTENTIAL CAUSES COULD BE ABNORMAL PATIENT ANATOMY, PATIENT NON-COMPLIANCE, ISSUES RELATED TO A SEPARATE SURGERY OR OTHER FACTORS. GIVEN THE PATIENT HAD NO ISSUES FOR TWO-YEARS IT IS DIFFICULT TO CONCLUSIVELY STATE THE PROBABLE ROOT CAUSE, THUS IT REMAINS UNKNOWN. A HISTORICAL SEARCH WAS CONDUCTED FROM 13OCT2024 TO 13OCT2025 AND FOUND THAT THIS WAS THE FIRST REPORT OF A DYNANAIL MINI REVISION SURGERY FROM AN UNKNOWN CAUSE OCCURRENCE. THIS IS AN ISOLATED CASE, AND THE FIRST OCCURRENCE REPORTED. THE PROBABLE ROOT CAUSE IS UNKNOWN. THE HAZARD IS AN ANTICIPATED RISK WITHIN THE RISK ANALYSIS MATRIX AND A SINGLE OCCURRENCE IS NOT AN INDICATION OF A SYSTEMATIC ISSUE NECESSITATING A CAPA INVESTIGATION. THEREFORE, NO FURTHER ACTION IS NEEDED.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980852 ACTIVE ADAPTIVE CONNECTION SCREW, M2.5, DYNANAIL MINI LXH MEDSHAPE, INC. UNKNOWN M97029002402500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other