CopiOs Extend 0190ZRecalls & 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
- 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 00813954020532), received between Sep 25, 2019 and Oct 8, 2024 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
LIMITED INFORMATION WAS PROVIDED. CUSTOMER REPORTED THE COPIOS EXTEND MEMBRANE OVERALL IS HARD TO SECURE. PATIENT CAME BACK FOR POST-OP AND THE MEMBRANE WASN'T THERE AND THIS WAS TWO WEEKS AFTER INITIAL SURGERY. A DELAY IN SURGERY WAS INDICATED SINCE THE IMPLANT WAS REMOVED AND THE PATIENT NEEDS TO HEAL BEFORE THE 2ND ATTEMPT. NO INDICATION OF IMPACT TO PATIENT WAS REPORTED. ADDITIONAL INFORMATION ON PATIENT OUTCOME WAS REQUESTED, BUT NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20398490 ↗InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CLINICIAN USED THE PRODUCT ON A PATIENT AND THE PATIENT CAME BACK COMPLAINING OF PAIN AND SWELLING AT THE SITE. THE CLINICIAN REMOVED THE MEMBRANE AND THE PATIENT HEALED ADEQUATELY. THE ADVERSE EVENTS INCLUDED SWELLING AND AN ALLERGIC REACTION.
Patient problems: No Code Available; Pain; Unspecified Infection
MAUDE report 9119260 ↗
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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 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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