OsseoGuard Flex OGF1520Recalls & reported problems
Collagen Matrix, Inc. · Resorbable Collagen Membrane for Dental Surgery 15mm x 20mm · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954020358), received between Dec 12, 2025 and Dec 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Osseointegration Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Osseointegration Problem; Osseointegration Problem
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
Patient problems: Insufficient Information
MAUDE report 23794923 ↗
Other Barrier, Animal Source, Intraoral devices
- GIBSON HEALTHCARE 5303-235Benco Dental Supply CO. · Barrier, Animal Source, Intraoral2 recalls0 reports
- GIBSON HEALTHCARE 5303-226Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-306Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-342Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-324Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- Neomem N1520Collagen Matrix, Inc. · Barrier, Animal Source, Intraoral1 recall0 reports
- BioMend 0103ZCollagen Matrix, Inc. · Barrier, Animal Source, Intraoral4 reports
- CopiOs Extend 0191ZCollagen Matrix, Inc. · Barrier, Animal Source, Intraoral3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.