SYMBIOS® USOSCRM1520Recalls & reported problems
Dentsply Implants Manufacturing GmbH · OsteoShield® Collagen Resorbable Membrane (15x20mm) · Class 2 · Implant
- 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 D716OSCRM15200), received between Dec 7, 2016 and Dec 7, 2016.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility1
Patient problems
- Foreign Body Reaction3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
Dec 7, 2016Patient-Device Incompatibility
CLINICIAN OBSERVED A FOREIGN BODY REACTION WITH THE USE OF THE MEMBRANE. THE CLINICIAN THOUGHT IT WAS CAUSED BY THE MEMBRANE BUT ALSO MENTIONED PATIENT BORN AND SURGICALLY BORN ISSUES MAY HAVE LED TO WHAT WAS OBSERVED. COMPLAINT STATES THAT THE PATIENT WAS NOT INJURED.
Patient problems: Foreign Body Reaction
MAUDE report 6153417 ↗Dec 7, 2016Adverse Event Without Identified Device or Use Problem
CLINICIAN OBSERVED A FOREIGN BODY REACTION WITH THE USE OF THE MEMBRANE. THE CLINICIAN THOUGHT IT WAS CAUSED BY THE MEMBRANE BUT ALSO MENTIONED PATIENT BORN AND SURGICALLY BORN ISSUES MAY HAVE LED TO WHAT WAS OBSERVED. COMPLAINT STATES THAT THE PATIENT WAS NOT INJURED.
Patient problems: Foreign Body Reaction
MAUDE report 6153413 ↗Dec 7, 2016Adverse Event Without Identified Device or Use Problem
CLINICIAN OBSERVED A FOREIGN BODY REACTION WITH THE USE OF THE MEMBRANE. THE CLINICIAN THOUGHT IT WAS CAUSED BY THE MEMBRANE BUT ALSO MENTIONED PATIENT BORN AND SURGICALLY BORN ISSUES MAY HAVE LED TO WHAT WAS OBSERVED. COMPLAINT STATES THAT THE PATIENT WAS NOT INJURED.
Patient problems: Foreign Body Reaction
MAUDE report 6153397 ↗
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.