MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA MESHED BILAYER WOUND MATRIX SIZE 4X5; N/A

Catalog Number	MWM4051
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A physician reported an integra meshed bilayer wound matrix size 4x5 (mwm4051) did not incorporate.The matrix was placed on (b)(6) 2024, 2024 in a 60-year old male patient with a diabetic foot ulcer (dorsum).The product worked well on the achilles wound but did not take in the dorsum of the foot.The surface area where the product did not incorporate was 30 centimeters while the size of the product required to reapply to surface area was 5x5 centimeters.The product was removed and replaced on (b)(6) 2024.
Additional Manufacturer Narrative
The integra meshed bilayer wound matrix (mwm4051) was not returned for evaluation as the product was implanted and it is not available for return as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined, however, the most likely cause is the underlying condition on the patient.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: INTEGRA MESHED BILAYER WOUND MATRIX SIZE 4X5
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21284226
• Report Number: 1121308-2025-00002
• Device Sequence Number: 12735463
• Product Code: KGN
• UDI-Device Identifier: 10381780032373
• UDI-Public: 10381780032373
• Combination Product (Y/N): N
• PMA/510(K) Number: K081635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: MWM4051
• Device Lot Number: 745279
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male