MAUDE Adverse Event Report: INTEGRA - ACELL(COLUMBIA) UNKNOWN CYTAL WOUND MATRIX

Catalog Number	XXX-CYTAL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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 facility reported cytal wound matrix (id (b)(6)) sheets are still very visible in the wound and not integrated or generating tissue, even after a full week with vac.No information was provided in regards patient impact.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h11.The cytal wound matrix was not returned for evaluation, however a photo was evaluated: dhr - no anomalies or nonconformances occurred during the manufacture or packaging of the device.Failure analysis - colleagues in production, product development, and manufacturing engineering reviewed the provided images.These smes concluded that the images are evidence of delamination, where the 2 layers separate.Although it is not possible to determine the number of layers present, the devices do appear thicker compared with typical product based on the translucency.It should be noted that there are no quantitative specifications for thickness or resorption time.The specification for thickness is ¿uniform thickness¿, which is meant to mean no thin spots or holes.Resorption time depends on numerous factors including patient biology and comorbidities.Root cause - the root cause cannot be determined based on the information available at this time.Additional information received: reason for wound matrix placement: "patient presented a wound that needed rapid granulation tissue to expedite closure." what specific signs indicated lack of integration? "matrix still intact/ minimal granulation" were there any adverse consequences to the patient? "none at all." was the wound matrix removed? if yes, please provide the date of removal.: "no we let the acell take its time to work as not all humans heal the same." what actions were taken to resolve the issue? "rehydrating sheet and letting sit in wound longer till fully incorporated." patient healing status.: "healed.".

• Brand Name: UNKNOWN CYTAL WOUND MATRIX
• Common Device Name: CYTAL
• Manufacturer (Section D): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; 6640 eli whitney drive; columbia MD 21046
• Manufacturer (Section G): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; columbia MD 21046
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22977402
• Report Number: 3005920706-2025-00017
• Device Sequence Number: 9540733
• Product Code: KGN
• UDI-Device Identifier: 00386190001035
• UDI-Public: 00386190001035
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: XXX-CYTAL
• Device Lot Number: 7477388
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown