MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. MEM-LOK RESORBABLE COLLAGEN MEMBRANE; COLLAGEN PERIODONTAL MEMBRANE

Model Number	RCM-ML2030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medical device report (mdr) is being submitted outside of the standard 30-day reporting timeframe due to corrective actions taken following a non-conformity identified during an mdsap audit / inspection.Quick resorption of this product can be related to the thermal properties of the device.As part of the manufacturer investigation for this event, analysis of production records confirmed all finished product testing met release criteria.One unit from reserve product inventory was tested for thermal transition temperature and the result met the acceptance criteria.
Event or Problem Description
This adverse event occurred outside of the u.S.However, as there is a similar marketed device in the u.S., an mdr is being filed.At the time of complaint initiation, limited information was provided.Customer stated the mem-lok resorbable collagen membrane was used on a patient on (b)(6) 2023.The patient returned on (b)(6) 2023 and the product material had resorbed.The patient was prescirbed medication - type of medication not specified.Further information was provided, where the customer clarified the patient was prescribed antibiotics (type of antibiotics not specified) before and after the procedure.There were no notable complications during the initial procedure.Revision surgery was performed in which the implants were extracted and the defect was covered again without any augmentation.No additional procedures were planned.Additional information surrounding the patient status, patient outcome, and event details were requested but not provided.No further information was provided.

• Brand Name: MEM-LOK RESORBABLE COLLAGEN MEMBRANE
• Common Device Name: COLLAGEN PERIODONTAL MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 23812070
• Report Number: 2249852-2025-00055
• Device Sequence Number: 15800116
• Product Code: NPL
• UDI-Device Identifier: 00813954020754
• UDI-Public: (01)00813954020754(17)251130(10)CMN221005
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K003339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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
• Device Expiration Date: 11/30/2025
• Device Model Number: RCM-ML2030
• Device Catalogue Number: RCM-ML2030
• Device Lot Number: CMN221005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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; Other
• Patient Sex: Unknown