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 Codes	Foreign Body Reaction (1868); Fluid Discharge (2686)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
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 08 november 2024 it was reported to anika that the healthcare provider (hpc) implanted an integrity patch on a 44-year-old patient on (b)(6) 2024 on the foot/ankle.The patient was seen by the hcp on (b)(6) 2024 for follow up.There is no report of any patient impact during this visit.On or about (b)(6) 2024 the hcp stated that the patient began to experience what is reported to be a reaction to the integrity patch.The patient reported what appeared to be a "zit" and upon squeezing it, a part of the patch came out of the enclosure site.The patient was cultured on (b)(6) 2024 (result of the closure was negative).The removal of the rest of the integrity patch was scheduled to occur on or about (b)(6) 2024 since the patient is starting to show signs of another sterile pustule where the piece of the integrity implant.The result of the procedure has not been provided at this time by the hcp.There was no report of any device malfunction at the time of use.There was no report of any unusual appearance with the device or packaging prior to use.Patient comorbidities is unknown.Additional information was solicited.
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) 2024 it was reported to anika that the healthcare provider (hpc) implanted an integrity patch on a 44-year-old patient on (b)(6) 2024 on the foot/ankle.The patient was seen by the hcp on (b)(6) 2024 for follow up.There is no report of any patient impact during this visit.On or about (b)(6) 2024 the hcp stated that the patient began to experience what is reported to be a reaction to the integrity patch.The patient reported what appeared to be a "zit" and upon squeezing it, a part of the patch came out of the enclosure site.The patient was cultured on (b)(6) (result of the closure was negative).The removal of the rest of the integrity patch was scheduled to occur on or about (b)(6) 2024 since the patient is starting to show signs of another sterile pustule where the piece of the integrity implant.The result of the procedure has not been provided at this time by the hcp.There was no report of any device malfunction at the time of use.There was no report of any unusual appearance with the device or packaging prior to use.Patient comorbidities is unknown.Additional information was solicited.
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: additional has not been provided by request.The batch record was reviewed.There was no nonconformances related to the reported event.The lot was manufactured and released to applicable procedures and specifications.The product lot retention inspection report was reviewed.There was no nonconformances documented in the report.A retrospective review of all nonconformances was performed for this product.There was no nonconformances related to the reported event.A clinical assessment could not establish a cause of the reported event and a temperal association could not be established between the use of the product and the patient experience.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 on this report.On 08 november 2024 it was reported to anika that the healthcare provider (hpc) implanted an integrity patch on a 44-year-old patient on (b)(6) 2024 on the foot/ankle.The patient was seen by the hcp on (b)(6) 2024 for follow up.There is no report of any patient impact during this visit.On or about (b)(6) 2024 the hcp stated that the patient began to experience what is reported to be a reaction to the integrity patch.The patient reported what appeared to be a "zit" and upon squeezing it, a part of the patch came out of the enclosure site.The patient was cultured on 9th of october (result of the closure was negative).The removal of the rest of the integrity patch was scheduled to occur on or about (b)(6) 2024 since the patient is starting to show signs of another sterile pustule where the piece of the integrity implant.The result of the procedure has not been provided at this time by the hcp.There was no report of any device malfunction at the time of use.There was no report of any unusual appearance with the device or packaging prior to use.Patient comorbidities is unknown.Additional information was solicited.
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: additional has not been provided by request.The batch record was reviewed.There was no nonconformances related to the reported event.The lot was manufactured and released to applicable procedures and specifications.The product lot retention inspection report was reviewed.There was no nonconformances documented in the report.A retrospective review of all nonconformances was performed for this product.There was no nonconformances related to thereported event.A clinical assessment could not establish a caue of the reported event and a temperal association could not be established between the use of the product and the patient experience.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.Supplemental report: udi number / date of manufacture was updated.A supplemental report will be submitted upon receipt of new and relevant information.

• 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: 20833552
• Report Number: 3007093114-2024-00024
• Device Sequence Number: 4159564
• Product Code: OWX
• UDI-Device Identifier: 00817337000258
• UDI-Public: 00817337000258
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K223538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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: 0000009882
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 01/17/2025; 01/23/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/17/2025; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2023
• 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: 44 YR
• Patient Sex: Female