MAUDE Adverse Event Report: ARTELON FLEXBAND FLEXBAND DYNAMIC MATRIX 0.7 X 16CM; MESH, SURGICAL, POLYMERIC

Catalog Number	31056
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Graft failure (4905)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
¿this case is part of a remediation performed by stryker following the acquisition of artelon company.This case has already concluded with minimal information.Therefore, no supplemental mdr will be submitted unless additional information is provided.¿.
Event or Problem Description
It was reported in review of manuscript for publication identified a deep infection."patient developed a deep postoperative infection following a revision orif ankle fracture with deltoid ligament reconstruction using puur graft, which required irrigation and debridement and graft removal.Of these major complications with return to the or, only the deep surgical site infection involved the puur graft.".
Event or Problem Description
It was reported in review of manuscript for publication identified a deep infection."patient developed a deep postoperative infection following a revision orif ankle fracture with deltoid ligament reconstruction using puur graft, which required irrigation and debridement and graft removal.Of these major complications with return to the or, only the deep surgical site infection involved the puur graft.".
Additional Manufacturer Narrative
Correction d4 udi, h6 results, conclusion.This investigation is part of the artelon remediation aiming to transfer the data history into tw.An investigation of this case has already been performed by artelon - please refer to attachment.There is no evidence that the deep infection was caused by the flexband device.As discussed in the manuscript the patients who developed minor and major complications had statistically significant higher rates of smoking and obesity compared to those that didn't develop infections or complications.This reported event of deep infection with removal of the flexband device and suture anchors occurred in a patient who smoked and was obese.This event was likely due to the patient underlying comorbidities and not a failure of the device.

• Brand Name: FLEXBAND FLEXBAND DYNAMIC MATRIX 0.7 X 16CM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ARTELON; 8601 dunwoody place; suite 250; sandy springs GA 30350
• Manufacturer (Section G): ARTELON; 8601 dunwoody place; suite 250; sandy springs GA 30350
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20939524
• Report Number: 3010673515-2024-00008
• Device Sequence Number: 4566282
• Product Code: FTL
• UDI-Device Identifier: 00868047000380
• UDI-Public: (01)00868047000380(11)171025(17)221130(10)A1710003
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 31056
• Device Lot Number: A1710003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2017
• 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