OsseoGuard OG2030Recalls & reported problems
Collagen Matrix, Inc. · Resorbable Collagen Membrane · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813954020334), received between Dec 23, 2019 and Dec 15, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Adverse Event Without Identified Device or Use Problem1
- Material Split, Cut or Torn1
Patient problems
- No Known Impact Or Consequence To Patient1
- Transmissible Spongiform Encephalopathy(TSE)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Transmissible Spongiform Encephalopathy(TSE)
MAUDE report 23812086 ↗InjuryDec 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THE CUSTOMER CLAIMED THAT THE MEMBRANE TORE DURING HANDLING. THE CLINICIAN WAS ABLE TO COMPLETE THE PROCEDURE USING ANOTHER MEMBRANE. THERE WERE NO SIGNIFICANT DELAYS OR ADVERSE EVENTS REPORTED ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9512434 ↗
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- 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.