MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. SOCKET REPAIR MEMBRANE; COLLAGEN DENTAL MEMBRANE

Model Number	0154
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint submitted through clinical literature search review.Limited information provided and it is unlikely further information surrounding the patient or event will be provided.Product part of the clinical literature search is socket repair membrane.No lot number or item number was specified.This single complaint was reported with multiple events.Title of the literature: beck, t.M., & mealey, b.L.(2010).Histologic analysis of healing after tooth extraction with ridge preservation using mineralized human bone allograft.Journal of periodontology, 81(12), 1765-1772.From the article, one site in the early healing group and two sites in the delayed healing group presented with signs of potential infection at the 7- to 10-day postoperative follow-up.No further information surrounding patient status or patient outcome was provided.The background of the study by beck and mealey (2010) investigated bone healing after tooth extraction when ridge preservation was performed using mineralized human bone allograft.The background highlights that significant alveolar bone loss typically follows extraction, and ridge preservation aims to mitigate this.The researchers compared healing outcomes at approximately 3 months versus 6 months post-extraction.Both time points showed similar results[?]around 45% new bone formation ]with no significant difference in residual graft material or connective tissue.

• Brand Name: SOCKET REPAIR 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: 22326930
• Report Number: 2249852-2025-00020
• Device Sequence Number: 9418634
• Product Code: NPL
• UDI-Device Identifier: 00813954020464
• UDI-Public: (01)00813954020464
• Combination Product (Y/N): N
• 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: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: 0154
• Device Catalogue Number: 0154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/25/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown