MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. INTEGRITY IMPLANT; MESH, SURGICAL, NON-ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number	6000100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: INTEGRITY IMPLANT
• Common Device Name: MESH, SURGICAL, NON-ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: lee perloff ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 23961382
• Report Number: 3007093114-2026-00001
• Device Sequence Number: 15859954
• Product Code: OWX
• UDI-Device Identifier: 00817337000241
• UDI-Public: 00817337000241
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6000100
• Device Lot Number: 0000012194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 64 KG