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

Model Number	RCM-ML1520
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
A complaint regarding mem-lok resorbable collagen membrane stating "graft failed at implant site #6, #7, and #8 due to infection.Patient care resolved by inserting a new graft".No other information regarding patient status has been provided.

• Brand Name: MEM-LOK RESORBABLE COLLAGEN MEMBRANE
• Common Device Name: COLLAGEN DENTAL 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: 24497510
• Report Number: 2249852-2026-00007
• Device Sequence Number: 5092129
• Product Code: NPL
• UDI-Device Identifier: 00813954020747
• UDI-Public: 00813954020747
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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 Model Number: RCM-ML1520
• Device Catalogue Number: RCM-ML1520
• Device Lot Number: CMN240503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown