BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY IMPLANT

    MDR report key: 23865936 · Received December 22, 2025

    Report

    Report Number
    3007093114-2025-00018
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    June 9, 2026
    Manufacturer
    ANIKA
    Product Code
    OWX
    UDI-DI
    00817337000258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    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 BY THE MANUFACTURING PLANT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE DISTRIBUTOR REPORTED THE FOLLOWING TO ANIKA SALES REPRESENTATIVE: PATIENT SURGERY WAS PERFORMED ON A 61-YEAR-OLD FEMALE ON (B)(6) 2025 FOR A PERONEAL TENDON TEAR USING AN INTEGRITY IMPLANT ANIKA PN 6000101 25MMX30MM LOT NUMBER 0000011809. PATIENT LATER DEVELOPED A LARGE CELL TUMOR AROUND HER PERONEAL TENDON. DOCTOR WAS ABLE TO REMOVE THE ABSCESS WITH AN ADDITIONAL SURGERY ON (B)(6) 2025. DOCTOR WAS ABLE TO GET THE AQUEOUS LAYER OUT. COMPLAINT SAMPLE DISCARDED. NO RADIOGRAPHS ARE AVAILABLE. NO INFECTIONS OCCURRED DUE TO IMPLANT. PATIENT IS CURRENTLY RECOVERING FROM THE SECOND SURGERY. PATIENT DISCHARGE SUMMARY NOT AVAILABLE. PATIENT COMORBIDITIES ARE UNKNOWN. POST TREATMENT PROTOCOLS HAVE BEEN FOLLOWED. ADDITIONAL INFORMATION IS BEING SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210598 INTEGRITY IMPLANT MESH, SURGICAL, NON-ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWX ANIKA 0000011809 00817337000258

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention