BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY IMPLANT SYSTEM

    MDR report key: 21562164 · Received March 10, 2025

    Report

    Report Number
    3007093114-2025-00004
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    November 15, 2024
    Report Date
    March 26, 2025
    Manufacturer
    ANIKA
    Product Code
    OWX
    UDI-DI
    00817337000258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION AT THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT IS NOT CONFIRMED. ADDITIONAL INFORMATION AND MEDICAL RECORDS WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED FOR THE REPORTED LOT. THERE WAS NO NONCONFORMANCES RELATED TO THE REPORTED INCIDENT. THE LOT WAS MANUFACTURED AND RELEASED TO APPLICABLE PROCEDURES AND SPECIFICATIONS. A THREE YEAR RETROSPECTIVE REVIEW OF ALL NONCONFORMANCES WAS PERFORMED FOR THE REPORTED PRODUCT. THERE WAS NO NONCONFORMANCES RELATED TO THE REPORTED EVENT. THE IFU WAS REVIEWED: WARNINGS, TEMPERATURE STORAGE, HANDLING PRECAUTIONS, AND GENERAL DEVICE-SPECIFIC INFORMATION ARE SUFFICIENTLY DOCUMENTED IN THE IFU. THE CASE WAS REVIEWED BY A CLINICIAN WHO CONCLUDED THAT THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE ESTABLISHED BASED ON THE INSUFFICIENT INFORMATION PROVIDED TO THE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. THIS CASE WILL BE MONITORED AND TRENDED FOR FUTURE ANALYSIS.

    Additional Manufacturer Narrative · 0

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

    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 12FEB2025 IT WAS REPORTED TO ANIKA THAT THE PATIENT OF UNKNOWN AGE AND DEMOGRAPHICS DIDN'T HEAL AND HAD A SMALL POST OP WOUND AND IT WAS REPORTED THAT A PART OF THE INTEGRITY PATCH WAS COMING OUT OF THE WOUND. THE PATIENT RECEIVED A REVISION PROCEDURE AND IS REPORTEDLY HEALING. ADDITIONAL INFORMATION WAS REQUESTED.

    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) 2025 IT WAS REPORTED TO ANIKA THAT THE PATIENT OF UNKNOWN AGE AND DEMOGRAPHICS DIDN'T HEAL AND HAD A SMALL POST OP WOUND AND IT WAS REPORTED THAT A PART OF THE INTEGRITY PATCH WAS COMING OUT OF THE WOUND. THE PATIENT RECEIVED A REVISION PROCEDURE AND IS REPORTEDLY HEALING. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173454 INTEGRITY IMPLANT SYSTEM MESH, SURGICAL, NON-ABSORBABLE, ORTHOPEDICS, REINFORCEMENT OF TENDON OWX ANIKA 0000010875 00817337000258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown