MAUDE Adverse Event Report: Anika Therapeutics, Inc Integrity; 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	Loss of Range of Motion (2032); Inadequate Pain Relief (2388); Limb Pain (4836)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A clinical study-related complaint was reported involving a retear of a surgically repaired rotator cuff in the right shoulder.The event was ongoing, non-serious, and described as mild, with outcome unknown.The event was classified as an adverse event and adverse device effect, and a causal relationship to the device was reported.The patient received a steroid injection to help treat the new tear and continued physical therapy.Additional information indicated that baseline and six-month post-operative mri images were provided, the product was not available for return, the clinician was very experienced with use of the device, there was no indication of mal-implantation, and symptoms appeared approximately 185 days after implantation.Follow-up physician notes indicated that at approximately six weeks post-operative the patient remained sore and requested an anti-inflammatory medication; due to reflux, celebrex was prescribed.The patient was still using a sling at that visit, was allowed to begin transitioning out of the sling, and planned to continue therapy.At approximately six months post-operative, the patient reported increased right shoulder pain without recalled trauma, ongoing discomfort, continued exercises and therapy, and slowly improving but persistent weakness.The notes indicated the patient was not using consistent pain medication at that time.The right subacromial space was injected with 2 cc of 0.25% marcaine mixed with medrol as a steroid injection, the patient tolerated the injection well, post-injection instructions were provided, and therapy was continued.This case will continue to be monitored and supplemented with any new relevant information.
Event or Problem Description
A post-market clinical follow-up notification was reported for a patient with a right shoulder retear following surgically repaired rotator cuff repair using an integrity patch.The event was ongoing at the time of reporting, described as mild, not serious, and classified as an adverse event/adverse device effect with a reported definite causal relationship; the outcome was unknown.The patient received a steroid injection at the 6-month follow-up visit to help treat the new tear and continued physical therapy.Additional information indicated that baseline and 6-month postoperative mri images were provided, the product was not available for return, the clinician was very experienced with use of the device, and there was no indication of mal-implantation.Symptoms were reported to have appeared approximately 185 days after device implantation.Follow-up notes indicated that at 6 weeks post right shoulder rotator cuff repair the patient remained sore, was prescribed anti-inflammatory medication, had the sling removed, and was directed to begin physical therapy.At the 6-month follow-up, the patient reported significant right shoulder pain without recalled trauma, ongoing discomfort prior to the flare, slow but improving strength, and continued exercises and therapy.Clinical assessment noted a traumatic chronic full-thickness rotator cuff tear in a previously operated rotator cuff, repaired with an integrity patch, with intraoperative findings including extensive labral tear, full-thickness supraspinatus and infraspinatus tear, and very soft bone causing the first anchor to pull out.Mri at follow-up did not show a full-thickness tear but did show partial-thickness bursal tearing.The patient had reasonable range of motion, cuff weakness, and functional weakness, and received a right subacromial injection for pain relief.This case will continue to be monitored and trended for future analysis.
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.
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.

• 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: 50155134
• Report Number: 3007093114-2026-00016
• Device Sequence Number: 9261133
• Product Code: OWX
• UDI-Device Identifier: 00817337000258
• UDI-Public: (01)00817337000258(17)280130(10)0000011808
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Consumer,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 0000011808
• 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: 06/09/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 161 LB