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

Catalog Number	6000101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Swelling/ Edema (4577)
Date of Event	02/17/2026
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 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.

• Brand Name: INTEGRITY IMPLANT
• Common Device Name: MESH, SURGICAL, NON-ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer (Section G): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: lee perloff ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 24793007
• Report Number: 3007093114-2026-00009
• Device Sequence Number: 8805340
• Product Code: OWX
• UDI-Device Identifier: 00817337000258
• UDI-Public: 00817337000258
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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: 6000101
• Device Lot Number: 0000012728
• 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: 03/13/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female