CopiOs Extend 0191ZRecalls & reported problems
Collagen Matrix, Inc. · Absorbable Collagen Membrane · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813954020549), received between Jan 26, 2022 and Jan 26, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).
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.
Most reported problems
Device problems
- Material Integrity Problem3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A DOCTOR NOTED AT #12 EXTRATION WITH A SEVERE BUCCAL DEFECT PATIENT AND WAS PLACED ON ANTIBIOTICS FOR 7 DAYS PRIOR TO SURGERY AND CONTINUED FOR 3 DAYS. BONE MATERIAL WAS PLACED WITH COPIOS MEMBRANE COMPLETE COVERING OF THE BONE AND EXTRACTED SITE WITH SUTURES. THE FOLLOWING WEEK, THE MEMBRANE HAD COMPLETELY DISSOLVED AND THE MAJORITY OF THE BONE MATERIAL HAD DISLODGED FROM THE SITE.
Patient problems: Insufficient Information
MAUDE report 13358478 ↗MalfunctionJan 26, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A DOCTOR NOTED AT #12 EXTRATION WITH A SEVERE BUCCAL DEFECT PATIENT AND WAS PLACED ON ANTIBIOTICS FOR 7 DAYS PRIOR TO SURGERY AND CONTINUED FOR 3 DAYS. BONE MATERIAL WAS PLACED WITH COPIOS MEMBRANE COMPLETE COVERING OF THE BONE AND EXTRACTED SITE WITH SUTURES. THE FOLLOWING WEEK, THE MEMBRANE HAD COMPLETELY DISSOLVED AND THE MAJOR BONE MATERIAL HAD DISLODGED FROM THE SITE.
Patient problems: Insufficient Information
MAUDE report 13358477 ↗MalfunctionJan 26, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A DOCTOR NOTED AT #12 TOOTH EXTRACTION, # 13 IMPLANTS PLACED ON SAME DAY NO ABCESS 50 N TORQUE ACHIEVED. BONE MATERIAL AND COPIOS MEMBRANE COVERED BOTH IMPLANTS. AT THE TWO WEEK FOLLOW UP, THE MEMBRANE COMPLETELY DISSOLVED AND BONE DISLODGED. NO ABCESS.
Patient problems: Insufficient Information
MAUDE report 13358109 ↗
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
- SYMBIOS® USOSCRM1520Dentsply Implants Manufacturing GmbH · Barrier, animal source, intraoral3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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