BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY

    MDR report key: 19777536 · Received July 18, 2024

    Report

    Report Number
    3007093114-2024-00014
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 25, 2024
    Report Date
    August 2, 2024
    Manufacturer
    ANIKA
    Product Code
    OWX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT IS NOT CONFIRMED. ADDITIONAL INFORMATION WAS NOT PROVIDED UPON REQUEST. A REVIEW OF THE BATCH RECORD WAS PERFORMED. THERE WAS NO NONCONFORMANCES RELATED TO THE REPORTED EVENT IN THE MANUFACTURING RECORD. THE PRODUCT WAS MANUFACTURED AND RELEASED TO APPLICABLE PROCEDURES AND SPECIFICATIONS. A RETROSPECTIVE REVIEW OF ALL NONCONFORMANCES WAS PERFORMED FOR THIS PRODUCT. THERE WERE NO NONCONFORMANCES RELATED TO THE REPORTED EVENT. THIS CASE WILL BE MONITORED AND TRENDED FOR FUTURE ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 27JUNE2024 THE CUSTOMER REPORTED TO ANIKA THAT A PATIENT OF UNKNOWN AGE AND DEMOGRAPHIC REPORTED PAIN AND SCHEDULED A SCOPE TO REMOVE LYSIS OF ADHESIONS. WHEN THE SURGEON PERFORMED THE PROCEDURE ON AN UNSPECIFIED DATE, THE SURGEON OBSERVED THAT THE INTEGRITY BONE STAPLE WAS FLOATING AND THAT THE MATRICES WAS ROLLED UP AND THE TACKS WERE NO LONGER FIXATED ON THE PATIENT'S TISSUE. THE BONE STAPLE AND TACKS WERE REVISED ON THE PATIENT. ADDITIONAL INFORMATION WAS SOLICITED. THIS REPORT IS FOR ONE OF TWO COMPONENTS OF THE INTEGRITY SYSTEM.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON (B)(6) 2024 THE CUSTOMER REPORTED TO ANIKA THAT A PATIENT OF UNKNOWN AGE AND DEMOGRAPHIC REPORTED PAIN AND SCHEDULED A SCOPE TO REMOVE LYSIS OF ADHESIONS. WHEN THE SURGEON PERFORMED THE PROCEDURE ON AN UNSPECIFIED DATE, THE SURGEON OBSERVED THAT THE INTEGRITY BONE STAPLE WAS FLOATING AND THAT THE MATRICES WAS ROLLED UP AND THE TACKS WERE NO LONGER FIXATED ON THE PATIENT'S TISSUE. THE BONE STAPLE AND TACKS WERE REVISED ON THE PATIENT. ADDITIONAL INFORMATION WAS SOLICITED. THIS REPORT IS FOR ONE OF TWO COMPONENTS OF THE INTEGRITY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646092 INTEGRITY MESH, SURGICAL, NON-ABSORBABLE, ORTHOPEDICS, REINFORCEMENT OF TENDON OWX ANIKA 0000009882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention