BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY IMPLANT

    MDR report key: 23961382 · Received January 5, 2026

    Report

    Report Number
    3007093114-2026-00001
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 1, 2025
    Report Date
    April 29, 2026
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    OWX
    UDI-DI
    00817337000241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. FOLLOW-UP: DURING A POST-MARKET CLINICAL EVALUATION, A PATIENT REQUIRED MEDICAL INTERVENTION FOR INCREASED SHOULDER PAIN WITH IMAGING FINDING CONCERNS OF NONHEALING OR RECURRENT TEAR AFTER IMPLANTATION. A SUBSEQUENT ROTATOR CUFF REPAIR WAS PERFORMED. THE EVENT WAS ASSESSED AS HAVING A TEMPORAL ASSOCIATION WITH USE OF THE PRODUCT; HOWEVER, A CAUSAL RELATIONSHIP COULD NOT BE ESTABLISHED AND THE REPORTER INDICATED THE ISSUE WAS LIKELY ATTRIBUTABLE TO POSTOPERATIVE NONCOMPLIANCE/STRAIN RATHER THAN THE IMPLANT. NO INFECTION WAS REPORTED, NO DEVICE MALFUNCTION OR PROCEDURAL DELAY WAS IDENTIFIED, AND THE PRODUCT WAS NOT AVAILABLE FOR RETURN. MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND SHOWED THE PRODUCT MET SPECIFICATIONS AND WAS MANUFACTURED AND RELEASED PER APPLICABLE PROCEDURES. A THREE YEAR RETROSPECTIVE REVIEW OF NONCONFORMANCE RECORDS AND RECORD-RETENTION INSPECTION LOGS FOUND NO ISSUES RELATED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE REVIEWED AND WERE CONSIDERED TO SUFFICIENTLY ADDRESS WARNINGS AND HANDLING/POSTOPERATIVE GUIDANCE. A CLINICAL REVIEW BY THE INTERNAL CLINICAL TEAM DID NOT YIELD ADDITIONAL INFORMATION.

    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 16DEC2025, THE FOLLOWING WAS REPORTED TO ANIKA: PATIENT SURGERY WAS PERFORMED ON A 54-YEAR-OLD MALE ON (B)(6) 2025 FOR A ROTATOR CUFF REPAIR OF SUPRASPINATUS TENDON USING AN INTEGRITY IMPLANT ANIKA PN 6000100 25MMX30MM LOT NUMBER 0000012194. NO RADIOGRAPHS TAKEN IMMEDIATELY AFTER IMPLANT SURGERY. NO INFECTION DUE TO IMPLANT. PRODUCT NOT AVAILABLE FOR RETURN. NO APPARENT MALFUNCTION. NO DELAY IN PROCEDURE. SUCCESSFUL ROTATOR CUFF REPAIR WAS COMPLETED. ON (B)(6) 2025, THE PATIENT FELT INCREASED PAIN DURING PHYSICAL THERAPY. ULTRASOUND SHOWS CONCERN FOR AREA OF NONHEALING OR RECURRENT TEAR, MRI ORDERED. ON (B)(6) 2025 THE FOLLOWING ADDITIONAL INFORMATION WAS REPORTED FROM PRIMARY CLINICAL SPECIALIST FOR SURGEON: AN MRI WAS COMPLETED ON (B)(6) 2025. THE MRI DID NOT SHOW A RETEAR OF THE ROTATOR CUFF REPAIR. IT IS BELIEVED THE ADVERSE EVENT WAS LIKELY DUE TO POOR COMPLIANCE AND MAY BE ATTRIBUTED TO SNOW SHOVELING. THIS IS NOT RELATED TO THE DEVICE. PATIENT'S COMORBIDITIES REPORTED ARE ANXIETY, HX OF STROKE, HYPERLIPIDEMIA. ADDITIONAL INFORMATION IS BEING SOLICITED.

    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 (B)(6) 2025, THE FOLLOWING WAS REPORTED TO ANIKA: PATIENT SURGERY WAS PERFORMED ON A 54-YEAR-OLD MALE ON (B)(6) 2025 FOR A ROTATOR CUFF REPAIR OF SUPRASPINATUS TENDON USING AN INTEGRITY IMPLANT ANIKA PN 6000100 25MMX30MM LOT NUMBER 0000012194. NO RADIOGRAPHS TAKEN IMMEDIATELY AFTER IMPLANT SURGERY. NO INFECTION DUE TO IMPLANT. PRODUCT NOT AVAILABLE FOR RETURN. NO APPARENT MALFUNCTION. NO DELAY IN PROCEDURE. SUCCESSFUL ROTATOR CUFF REPAIR WAS COMPLETED. ON (B)(6) 2025, THE PATIENT FELT INCREASED PAIN DURING PHYSICAL THERAPY. ULTRASOUND SHOWS CONCERN FOR AREA OF NONHEALING OR RECURRENT TEAR, MRI ORDERED. ON (B)(6) 2025 THE FOLLOWING ADDITIONAL INFORMATION WAS REPORTED FROM PRIMARY CLINICAL SPECIALIST FOR SURGEON: AN MRI WAS COMPLETED ON (B)(6) 2025. THE MRI DID NOT SHOW A RETEAR OF THE ROTATOR CUFF REPAIR. IT IS BELIEVED THE ADVERSE EVENT WAS LIKELY DUE TO POOR COMPLIANCE AND MAY BE ATTRIBUTED TO SNOW SHOVELING. THIS IS NOT RELATED TO THE DEVICE. PATIENT'S COMORBIDITIES REPORTED ARE ANXIETY, HX OF STROKE, HYPERLIPIDEMIA. ADDITIONAL INFORMATION IS BEING SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265445 INTEGRITY IMPLANT MESH, SURGICAL, NON-ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWX ANIKA THERAPEUTICS, INC. 0000012194 00817337000241

    Patients

    Seq Age Sex Outcome Treatment
    1