MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. OSSEOGUARD; COLLAGEN DENTAL MEMBRANE III

Model Number	OG1520
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medical device report (mdr) is being submitted outside the standard 30-day reporting timeframe due to corrective actions taken following a nonconformity identified during an mdsap audit /inspection.
Event or Problem Description
This adverse event occurred outside of the u.S.However, as there is a similarly marketed device in the u.S., an mdr is being filed.Patient had an unspecified procedure performed on (b)(6) 2024.Osseoguard resorbable membrane was used on a patient in tooth sites 46 and 47 in conjunction with puros 67210 + 67212 (puros product is not manufactured by collagen matrix, inc.).Customer states the membrane "dissolved in 3 days." on (b)(6) 2024, it was reported the patient had an allergic reaction with "strong swelling, abscess, inflammation, redness and collection of pus" and the wound would not heal.The patient reported "great pain." the customer stated the product was removed on (b)(6) 2024.It is unclear which product was removed, but customer believes it was the puros product removed.Customer stated the patient is "ok after removal of the material." there is no treatment plan finalized yet, as the patient and clinician are "making decisions, possibly transfer to oral and maxillofacial surgery." additional clarification surrounding the dates and events and patient status/patient outcome was requested but not yet provided.

• Brand Name: OSSEOGUARD
• Common Device Name: COLLAGEN DENTAL MEMBRANE III
• 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: 23794863
• Report Number: 2249852-2025-00059
• Device Sequence Number: 10471186
• Product Code: NPL
• UDI-Device Identifier: 00813954020327
• UDI-Public: (01)00813954020327(17)260331(10)CM3N23B2
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/12/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: OG1520
• Device Catalogue Number: OG1520
• Device Lot Number: CM3N23B2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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: Other; Required Intervention
• Patient Sex: Unknown