BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 21579853 · Received March 11, 2025

    Report

    Report Number
    3007593722-2025-00002
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    February 14, 2025
    Report Date
    September 4, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HSB
    UDI-DI
    M97029000700000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE H6 AND H11. THE COMPLAINT WAS OPENED FOR A REPORT FOR A DYNANAIL MINI REVISION SURGERY THAT OCCURRED TO REMOVE THE IMPLANT DUE TO THE PROXIMAL INTERLOCK HAVING BACKED OUT AND A NON-UNION OF THE MEDIAL COLUMN. THE ORIGINAL SURGERY DATE IS UNKNOWN, AND THE ORIGINAL PHYSICIAN OF THE SURGERY IS ALSO UNKNOWN. THE SAMPLE WAS DISCARDED AT THE FACILITY SO A COMPLETE EVALUATION AND INVESTIGATION COULD NOT BE CONDUCTED. IN A REVIEW OF THE DYNANAIL MINI RISK MATRIX THE POTENTIAL FAILURE MODE OF FIXATION SCREWS BACKING OUT OF BONE IS RECORDED AND ACCOUNTED FOR. THE POTENTIAL CAUSE OF THE FAILURE IS DOCUMENTED AS INSUFFICIENT FRICTION OF SCREW THREADS TO BONE. OTHER POTENTIAL CAUSES OF FAILURE COULD BE IMPROPER SURGICAL TECHNIQUE OR PATIENT NON-COMPLIANCE. THE HAZARD IS RANKED WITH A DETECTION SCORE OF 1, SEVERITY OF 3 AND OCCURRENCE OF 1. AFTER A HISTORICAL SEARCH FROM THE TIME FRAME OF 03/01/20204 TO 03/01/2025, IT WAS CONCLUDED THAT THIS WAS THE FIRST OCCURRENCE OF THIS FAILURE MODE TO THIS PRODUCT FAMILY. THIS IS AN ISOLATED CASE, AND THE FIRST OCCURRENCE REPORTED. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148499 ACTIVE ADAPTIVE DYNANAIL MINI HSB MEDSHAPE, INC. UNKNOWN M97029000700000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention