BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 22909904 · Received August 27, 2025

    Report

    Report Number
    3007593722-2025-00015
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    July 30, 2025
    Report Date
    October 23, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS OPENED IN RESPONSE OF A REPORT OF A DYNACLIP STAPLE REVISION SURGERY. THE MODEL AND SIZE OF THE IMPLANT IS UNKNOWN; THE SAMPLE WAS NOT RETURNED NOR WERE VISUALS OF THE DEVICE PROVIDED THAT WOULD HAVE HELPED IN DETERMINING A PROBABLE ROOT CAUSE FOR THE FAILURE AND REMOVAL. THE DYNACLIP RISK MATRIX WAS REVIEWED. THOUGH THE ROOT CAUSE FOR THE REMOVAL OF THE STAPLE IS UNKNOWN, MULTIPLE CAUSES ARE ACCOUNTED FOR IN THE RISK MATRIX THAT COULD LEAD TO REVISION/REMOVAL SURGERY INCLUDING BREAKAGE, NON-FUSION, INFECTION, AND MIGRATION. IN THE RISK MATRIX, THESE FAILURE MODES ARE LISTED WITH THE POTENTIAL CAUSES OF FAILURE AS MANUFACTURING ERROR, IMPROPER DIMENSIONS, IMPROPER DRILL SPACING, INADEQUATE COMPRESSION STRENGTH, ABNORMAL ANATOMY CAUSES EXCESSIVE STRAINS ON THE STAPLE, OR A FAILED FUSION. IT IS UNKNOWN IF THE SURGICAL TECHNIQUE WAS ADHERED TO AS WELL AS IF THE PATIENT WAS COMPLIANT WITH THE INFORMATION PROVIDED, BUT THERE WERE NO REPORTED DEVIATIONS. WITH THE INFORMATION PROVIDED, A DEFINITIVE PROBABLE ROOT CAUSE REMAINS UNKNOWN. THE POTENTIAL FAILURES ARE RANKED WITH A DETECTION SCORE OF 2, DEVICE AND PATIENT SEVERITY OF EITHER 3 OR 4, AND OCCURRENCE OF 1. A HISTORICAL SEARCH WAS CONDUCTED IN THE TIMEFRAME OF 07/30/2024 TO 07/30/2025 AND RESULTS SHOWED THAT THIS WAS THE SECOND OCCURRENCE OF A COMPLAINT FOR THIS FAILURE MODE TO THE DYNACLIP FAMILY. BASED ON DYNACLIP PRODUCT FAMILY SALES VOLUME OF 3766 IN THE TIMEFRAME, THE OCCURRENCE LEVEL OF REMOTE IS APPROPRIATE AND OVER THE YEAR OCCURRED AT A (B)(4) RATE. THE HAZARD IS AN ANTICIPATED RISK WITHIN THE RISK ANALYSIS MATRIX AND THE CURRENT OCCURRENCES ARE WITHIN THE ANTICIPATED THRESHOLD. THUS, THIS IS NOT AN INDICATION OF A SYSTEMATIC ISSUE NECESSITATING A CAPA INVESTIGATION. THE DYNACLIP RISK ANALYSIS MATRIX RISK-FA005-0001, REV A, WAS GENERATED USING THE LEGACY MEDSHAPE RISK MANAGEMENT SOP. OCCURRENCE LEVEL COMPARISON IS IN ALIGNMENT WITH THAT PROCEDURE.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697656 ACTIVE ADAPTIVE UNKNOWN PART FOR ACTIVE ADAPTIVE JDR MEDSHAPE, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention