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

Model Number	OGF1520
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2023
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.Complaint received through clinical data collection.An osseoguard flex membrane was utilized during a procedure for filling of bone defects after root resection, cystectomy or removal of retained teeth on (b)(6) 2023.The clinician reported loss of bone graft material.The membrane was hydrated prior to placement with sterile saline.Bio-oss bone graft material was also used.Sutures were used to stabilize the membrane in place 5.0 coralene.Primary closure was achieved.No other products were used, no complications occurred during implantation and no other concomitant medical treatment was performed.Post-operative instructions included antimicrobial oral rinse perio-aid.Follow up visit occurred (b)(6) 2023 for implant placement.Wound healing uneventful.Adverse event observed: loss of bone graft material.Surgical/medical intervention was required, extra bone graft and membrane.Periodontal defect regeneration was successful.Dental implant was placed.Membrane resorption assessment: 0 - membrane not visually present.Post-operative instructions included antimicrobial oral rinse perio-aid.No other patient information was made available.

• Brand Name: OSSEOGUARD FLEX
• Common Device Name: COLLAGEN DENTAL MEMBRANE IV
• 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: 23794923
• Report Number: 2249852-2025-00066
• Device Sequence Number: 17523359
• Product Code: NPL
• UDI-Device Identifier: 00813954020358
• UDI-Public: (01)00813954020358(17)250131(10)BDMU22A1
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K090216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• 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: 01/31/2025
• Device Model Number: OGF1520
• Device Catalogue Number: OGF1520
• Device Lot Number: BDMU22A1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2022
• 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
• Patient Sex: Unknown