MAUDE Adverse Event Report: Anika Therapeutics, Inc Integrity; Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

Model Number	6000102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Limb Pain (4836)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An adverse event was reported from an integrity pmcf study involving the shoulder.The subject reported continued stiffness and limited motion in the operated shoulder, and a glenohumeral injection was performed.The event began on (b)(6) 2026 and was ongoing at the time of reporting, with no end date available.Symptoms were mild, the event was not serious, and no serious health threat was reported.The safety event was classified as an adverse event, device classification was not applicable, causality was assessed as possible/uncertain, and the outcome was reported as resolving.This case will updated with any new relevant information.
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information orupon completion of the inv estigation by the manufacturing plant.

• Brand Name: Integrity
• Common Device Name: Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
• Manufacturer (Section D): Anika Therapeutics, Inc; 32 wiggens avenue; bedford MA 01730
• Manufacturer Contact: heather iwaniuk ; 32 wiggens avenue; bedford, MA 01730
• MDR Report Key: 50273620
• Report Number: 3007093114-2026-00021
• Device Sequence Number: 10255913
• Product Code: OWX
• UDI-Device Identifier: 00817337000258
• UDI-Public: (01)00817337000258(17)260506(10)Lot75AE1142
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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 Expiration Date: 05/06/2026
• Device Model Number: 6000102
• Device Lot Number: 75AE1142
• 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: 08/11/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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 Sex: Unknown