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

Catalog Number	6000101
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
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 at 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 on this report.On (b)(6) 2025 it was reported to anika that the patient of unknown age and demographics didn't heal and had a small post op wound and it was reported that a part of the integrity patch was coming out of the wound.The patient received a revision procedure and is reportedly healing.Additional information was requested.
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 at the manufacturing plant.Supplemental report: the reported event is not confirmed.Additional information and medical records was requested but not provided.The device was not available for analysis.The batch record was reviewed for the reported lot.There was no nonconformances related to the reported incident.The lot was manufactured and released to applicable procedures and specifications.A three year retrospective review of all nonconformances was performed for the reported product.There was no nonconformances related to the reported event.The ifu was reviewed: warnings, temperature storage, handling precautions, and general device-specific information are sufficiently documented in the ifu.The case was reviewed by a clinician who concluded that the cause of the reported incident could not be established based on the insufficient information provided to the manufacturer.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored and trended for future analysis.
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 on this report.On 12feb2025 it was reported to anika that the patient of unknown age and demographics didn't heal and had a small post op wound and it was reported that a part of the integrity patch was coming out of the wound.The patient received a revision procedure and is reportedly healing.Additional information was requested.

• Brand Name: INTEGRITY IMPLANT SYSTEM
• Common Device Name: MESH, SURGICAL, NON-ABSORBABLE, ORTHOPEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 21562164
• Report Number: 3007093114-2025-00004
• Device Sequence Number: 4527373
• Product Code: OWX
• UDI-Device Identifier: 00817337000258
• UDI-Public: 00817337000258
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/29/2025
• Device Catalogue Number: 6000101
• Device Lot Number: 0000010875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• 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
• Patient Sex: Unknown