MAUDE Adverse Event Report: ANIKA THERAPEUTICS 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 Code	Post Operative Wound Infection (2446)
Date of Event	03/22/2026
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
A distributor reported the following to anika: the product involved is the integrity implant, indicated for achilles tendon repair.The procedure was performed on (b)(6) 2026 on a female patient aged over 60 years old, with no history of diabetes and an active lifestyle.The implant used measured 25mm x 30mm, with lot number 000012728 and expiry date of 28 july 2028.The patient was diagnosed with a mid-substance achilles tendon tear confirmed via mri.Surgical intervention involved achilles tendon repair with suture and integrity augmentation, utilizing vicryl plus 4-0 sutures.No intraoperative complications were reported.Postoperatively, the patient developed complications.On (b)(6) 2026, the wound was observed to have partial gaping.Between (b)(6) 2026, the wound was debrided and subsequently closed.However, in (b)(6) 2026, following sto, the wound remained gaping.An infection was observed several weeks after the initial surgery, which ultimately necessitated the removal of the integrity augmentation.This event has been classified as a postoperative wound complication with associated infection." product: integrity implant, indication used: achilles tendon repair, report type: postoperative wound complication, case date: (b)(6) 2026, patient: 60+ years old (f) / no diabetes, patient details: active traveler (oversea 2 months once) / traumatic rupture, product name: integrity implant, implant size: 25mm x 30 mm, lot/batch no.: 000012728, expiry date: 28/07/2028, indication: achilles tendon repair, surgical details, initial procedure: (b)(6) 2026, diagnosis: mid-substance achilles tendon tear (mri confirmed), procedure: achilles tendon repair with suture & integrity augmentation, suture used: vicryl plus 4-0 (to augment integrity), intraoperative: no immediate complications reported.

• Brand Name: INTEGRITY IMPLANT
• Common Device Name: MESH, SURGICAL, NON-ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ANIKA THERAPEUTICS; 32 wiggens avenue; bedford MA 01730
• Manufacturer Contact: iwaniuk ; 32 wiggens avenue; bedford, MA 01730
• MDR Report Key: 25430695
• Report Number: 3007093114-2026-00011
• Device Sequence Number: 13339646
• Product Code: OWX
• UDI-Device Identifier: 00817337000258
• UDI-Public: 00817337000258
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: 000012728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/17/2026
• 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: 60 YR
• Patient Sex: Female