BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY IMPLANT

    MDR report key: 24793007 · Received April 6, 2026

    Report

    Report Number
    3007093114-2026-00009
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    February 17, 2026
    Report Date
    April 6, 2026
    Manufacturer
    ANIKA
    Product Code
    OWX
    UDI-DI
    00817337000258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    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 IN THIS REPORT. ON 13MAR2026 OUR COMMERCIAL MANAGER WAS NOTIFIED BY A DOCTOR STATING THAT HE PERFORMED A ROTATOR CUFF REPAIR ON A 54-YEAR-OLD FEMALE PATIENT ON (B)(6) 2026 USING AN ANIKA 25X30MM INTEGRITY IMPLANT PN 6000101 LN 0000012728 UTILIZING AN INTEGRITY IMPLANT FIXATION KIT PN 6000102 LOT: 75AE1142. ON (B)(6) 2026 THE DOCTOR STATED THAT HE BELIEVES THE INTEGRITY IMPLANT CAUSED AN INFLAMMATORY RESPONSE AND EXTREME SWELLING IN THE PATIENT'S SHOULDER. THE PATIENT HAD TO BE RETURNED TO THE OR FOR THE GRAFT TO BE REMOVED AND RESOLVE THE PATIENT'S INFLAMMATORY RESPONSE. THE DOCTOR STATED THIS LOOKS LIKE AN EXTREME BODILY RESPONSE TO THE GRAFT AND TOWARDS THE ANTERIOR PORTAL IN THE PATIENT'S SHOULDER. DOCTOR ALSO TOLD THE COMMERCIAL MANAGER THAT HE GOT CULTURES OF THIS PATIENT TO SEE IF IT WAS INFECTION THAT WAS CAUSING THIS PROBLEM AND LAB CULTURES CAME BACK AS NEGATIVE FOR INFECTION. UPON REMOVAL OF THE IMPLANT, THE PATIENT IS DOING BETTER NOW. DOCTOR STATED THIS SAMPLE IS NOT AVAILABLE FOR RETURN AS IT HAS BEEN DISCARDED. ADDITIONAL INFORMATION IS BEING SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856230 INTEGRITY IMPLANT MESH, SURGICAL, NON-ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWX ANIKA 0000012728 00817337000258

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention