MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. GIBSON HEALTHCARE BONE GRAFTING; SYNOSS COLLAGEN SYNTHETIC MINERAL COLLAGEN BONE GRAFT MATRIX

Model Number	5824-413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A complaint was received regarding a gibson healthcare bone graft plug, stating the "item exploded in the patient's mouth".On (b)(6) 2025, a patient underwent an extraction and graft procedure on tooth #14.On (b)(6) 2025, medical intervention was required and the clinician removed the bone graft plug and replaced with a different bone graft plug (osteogen, not a cmi product).There was no indication of a surgical delay.No further information regarding patient status or patient outcome was provided.

• Brand Name: GIBSON HEALTHCARE BONE GRAFTING
• Common Device Name: SYNOSS COLLAGEN SYNTHETIC MINERAL COLLAGEN BONE GRAFT MATRIX
• 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: 22568567
• Report Number: 2249852-2025-00036
• Device Sequence Number: 3994421
• Product Code: LYC
• UDI-Device Identifier: 00813954024233
• UDI-Public: (01)00813954024233(17)270731(10)SMCN240602
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 07/22/2025

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 Model Number: 5824-413
• Device Catalogue Number: 5824-413
• Device Lot Number: SMCN240602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2024
• 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