CopiOs Extend 0192ZRecalls & reported problems
Collagen Matrix, Inc. · Absorbable Collagen Membrane · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813954020556), received between Oct 2, 2017 and Dec 15, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Material Disintegration1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
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. LIMITED INFORMATION PROVIDED. IT WAS REPORTED THE COPIOS EXTEND MEMBRANE FAILED TO INTEGRATE WHEN TOOTH SITES UR3 AND UR4 WERE GRAFTED TOGETHER WITH THE DEVICE. THE PATIENT EXPERIENCED INFLAMMATION. CUSTOMER STATED REVISION SURGERY WILL BE REQUIRED, AS THE PATIENT WILL NEED TO RETURN TO THE OFFICE TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, INCLUDING PATIENT INFORMATION, EVENT INFORMATION, PATIENT IMPACT INFORMATION, AND INFORMATION SURROUNDING THE REVISION SURGERY (PATIENT OUTCOME FROM REVISION SURGERY AND DATE OF REVISION SURGERY), HOWEVER IT WAS NOT PROVIDED. ADDITIONALLY, NO INFORMATION SURROUNDING POTENTIAL DEVICE MALFUNCTION OR FURTHER INFORMATION SURROUNDING PATIENT IMPACT WAS PROVIDED. NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23812377 ↗MalfunctionOct 2, 2017Material Disintegration; Material Disintegration
THE CLINICIAN REPORTED THAT THE MEMBRANE DID NOT HOLD FORM AND DISINTEGRATED 2 DAYS FOLLOWING THE IMPLANTATION. NO INFORMATION WAS PROVIDED WHETHER PRIMARY CLOSURE WAS ACHIEVED AND THE CLINICIAN DID NOT REPORT ANY ADVERSE REACTIONS OR PATIENT INJURY AS A RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6908791 ↗
Other Barrier, Animal Source, Intraoral devices
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- 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.