BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCAD

    MDR report key: 6053709 · Received October 25, 2016

    Report

    Report Number
    3010673777-2016-00001
    Event Type
    Injury
    Date Received
    October 25, 2016
    Report Date
    October 24, 2016
    Manufacturer
    NOVASTEP
    Product Code
    JDR
    UDI-DI
    03700879501284
    PMA / PMN Number
    K142111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT # (B)(4). OPENED: ALL INVESTIGATIONS DONE AT THIS TIME CONFIRMED THESE BATCHES OF ARCAD WERE PRODUCED AND CONTROLLED CONFORM TO NOVASTEP SPECIFICATIONS. DEVICE NOT EXPLANTED.

    Description of Event or Problem · 1

    DURING A SALES REP VISIT ON (B)(6) 2016 IT WAS REPORTED TO NOVASTEP SALES REP. THAT DURING THE LAST 12 MONTH 3 CASES HAVE CONDUCTED TO ARCAD 18 COMPRESSIVE STAPLE BREAKAGE. THIS THE SAME SURGEON FOR THESE 3 CASES. FIRST CASE : ARCAD 18-14-16 COMPRESSIVE STAPLE WAS DETECTED AS BROKEN BY THE SURGEON DURING THE ANALYSIS OF XRAY PERFORMED DURING A PATIENT FOLLOW UP VISIT. THE SURGEON EXPECTS THAT THE USE OF ONLY TWO ARCAD 18 STAPLES TO PROCEED MTP ARTHRODESIS TO BE TOO WEAK. ASSEMBLY SHOULD HAVE BEEN DONE USING BIGGER STAPLES OR ADDITIONAL DEVICES ASSOCIATED WITH TWO ARCAD 18 COMPRESSIVE STAPLES. THE 2 OTHERS CASES HAVE BEEN REPORTED IN REPORT 3010673777-2016-00002, 3010673777-2016-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707278 ARCAD STAPLE JDR NOVASTEP ARCAD C00552 03700879501284

    Patients

    Seq Age Sex Outcome Treatment
    1 Other