BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICONIX 25 WITH INTELLIBRAID TECHNOLOGY 2.3MM ANCHOR WITH 2 STRANDS 5 FORCE FIBER

    MDR report key: 4221795 · Received November 3, 2014

    Report

    Report Number
    0002936485-2014-00877
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    April 7, 2014
    Report Date
    October 14, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    MBI
    PMA / PMN Number
    K120509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANCHOR WAS NOT RETURNED AND THE FAILURE MODE WAS NOT CONFIRMED. ON (B)(6) 2014, IT WAS REPORTED THAT ON THIS CASE OF PATIENT INFECTION, THE PATIENT'S INFECTION IS NOT RELATED TO THE IMPLANTS. SALES REPRESENTATIVE REPORTED THE CASES EVEN THOUGH THEY KNOW THAT THE INFECTION IS NOT PRODUCT RELATED, FOLLOWING STRYKER'S EVENT REPORTING POLICY. NEVERTHELESS, THE DEVICE HISTORY RECORD (DHR) OF THE REPORTED LOT WAS REVIEWED. THE STERILIZATION PROCESS WAS PERFORMED TO SPECIFICATION WITH NO NONCONFORMANCE FOUND. IN SUM, THE PRODUCT WAS NOT RETURNED AND THE FAILURE MODE WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS ASSOCIATED WITH A REVISION SURGERY AS A RESULT OF AN INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS ASSOCIATED WITH A REVISION SURGERY AS A RESULT OF AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703978 ICONIX 25 WITH INTELLIBRAID TECHNOLOGY 2.3MM ANCHOR WITH 2 STRANDS 5 FORCE FIBER FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI STRYKER ENDOSCOPY-SAN JOSE 13276AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR