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

Model Number	OG3040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transmissible Spongiform Encephalopathy(TSE) (4556)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
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.The customer initially reported a complaint for an unknown and unspecified reason on (b)(6) 2023, with no patient information or event information provided.Additional information was requested from the customer.On (b)(6) 2023 the customer provided additional information.The customer reported a healthy, 76-year-old male patient underwent guided bone regeneration surgery for a sinus filling (in locations 23 and 25) on (b)(6) 2018 using the osseoguard resorbable membrane.Product the patient developed creutzfeldt-jakob disease in 2023.The specific date of diagnosis was not specified.The variant type of creutzfeldt-jakob disease was requested multiple times but not provided.The patient is currently hospitalized in critical condition with a short-term viral prognosis.No further information surrounding patient status provided.
Additional Manufacturer Narrative
This medical device report (mdr) is being submitted outside the standard 30-day reporting timeframe due to corrective actions taken following an nonconformity identified during an mdsap audit/inspection.As part of the manufacturer investivgation into this reported adverse event, analysis of production records confirmed the production lot associated with this complaint met the release criteria, including the raw material purification process and supplier certificate of conformance for the raw bovine material.The purification process and supplier certificate of conformance confirmed to collagen matrix, inc.'s specifications.The sterilization and finish product testing of the finished product were normal.All tests were well within collagen matrix, inc.'s specifications and not close to a limit.There were no anomalies noted.It was confirmed the source of bovine tendon material is carried out in accordance with iso 22442-2 and the manufacturing process is established and followed to minimize the load of viruses and potential transmissible spongiform encephalopathies (tses).The viral inactivation process established by collagen matrix, inc.Was also followed.The donor cattle are sourced from bovine spongiform encephalopathy (bse) negligible risk countries (new zealand and australia).No case of bse has ever been reported in new zealand.The risk associated with viruses and transmissible agents are continuously evaluated and monitored through the risk management program.Achilles tendon tissues are sourced from young, healthy bovine, 30 months of age or younger.Younger cattle are considered lower risk than older animals.The nature of the starting material (bovine achilles tendon tissue) is considered low-risk material for harbouring tse infectivity.Various scientific studies have been conducted to determine the distribution of infectivity and prion protein in cattle with bse.Based on these scientific results, the world health organization has classified bovine tendon tissues as a category ic "tissues with no detectable infectivity." australia and new zealand are recognized as having negligible bse risk and are considered safe sources.It was concluded that the residual risk of use of the use of bovine animal tissue is an acceptable risk that is lower than the risk the acquire the sporadic form of human tse (creutzfeldt-jakob disease).The specific variant of creutzfeldt-jakob disease (sporadic cjd or variant cjd) was requested from the customer multiple times, but the customer was unable to confirm the variant.Additionally, a manufacturer's clinical assessment of the event was conducted, in which epidemiological data, prevalence of the disease, forms of cjd, median age at death (different forms) and evidence through literature that cases of variant cjd (vcjd) resulted from eating meat products was reviewed.The source of bovine tendon material is carried out in accordance with iso 22442-2 and the manufacturing process is established and followed to minimize the load of viruses and potential transmissible spongiform encephalopathies (tses).It was reported the patient has a pre-existing condition, however it is unknown what the pre-existing condition is; no information on the pre-existing condition was provided.Additionally, there is strong evidence that primary cases of vcjd resulted from eating meat products and specific variant of cjd (sporadic cjd or variant cjd) is unknown, therefore it is unlikely that the adverse event is related to the product in question.As collagen matrix, inc.'s sourcing controls and inactivation procedures for tse were followed, it is extremely unlikely this adverse event is related to the device in question.

• Brand Name: OSSEOGUARD MEMBRANE
• 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: 23812086
• Report Number: 2249852-2025-00051
• Device Sequence Number: 9359797
• Product Code: NPL
• UDI-Device Identifier: 00813954020334
• UDI-Public: (01)00813954020334(17)200831(10)CM3N17J1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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: 08/31/2020
• Device Model Number: OG3040
• Device Catalogue Number: OG3040
• Device Lot Number: CM3N17J1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2017
• 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: Hospitalization; Other
• Patient Age: 76 YR
• Patient Sex: Male