BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNACLIP DELTA

    MDR report key: 22722965 · Received August 5, 2025

    Report

    Report Number
    3007593722-2025-00013
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 8, 2025
    Report Date
    October 7, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    JDR
    PMA / PMN Number
    D481243
    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 ON ACCOUNT OF A DYNACLIP DELTA REVISION REMOVAL SURGERY. THE SAMPLE WAS NOT RETURNED THUS A COMPLETE EVALUATION AND INVESTIGATION COULD NOT BE CONDUCTED. NO CONCLUSION COULD BE DRAWN ABOUT THE PROBABLE CAUSE OF THE FAILURE FROM THE INFORMATION PROVIDED ON THE CASE. THE CAUSE FOR REMOVAL REMAINS UNKNOWN. 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 07/10/2024 TO 07/10/2025 AND RESULTS SHOWED THAT THIS WAS THE FIRST OCCURRENCE OF A COMPLAINT FOR A REVISION SURGERY WITH AN UNKNOWN CAUSE TO THE DYNACLIP FAMILY. BASED ON DYNACLIP PRODUCT FAMILY SALES VOLUME IN THE TIMEFRAME OF 3784, THE OCCURRENCE LEVEL OF REMOTE IS APPROPRIATE. 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 WAS GENERATED USING THE LEGACY MEDSHAPE RISK MANAGEMENT SOP. OCCURRENCE LEVEL COMPARISON IS IN ALIGNMENT WITH THAT PROCEDURE. 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. IT WILL CONTINUE TO BE MONITORED. THEREFORE, NO FURTHER ACTION IS NEEDED.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377850 DYNACLIP DELTA DELTA DYNACLIP STAPLE, 24X16X14X12 JDR MEDSHAPE, INC. 17393

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female Required Intervention