OSSIX® VOLUMAX OXV1525Recalls & reported problems
Datum Dental Ltd · Resorbable collagen membrane · Class 2 · Implant
Data updated Oct 18, 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 07290015477123), received between Feb 10, 2023 and Mar 7, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Discolored” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Discolored1
- Osseointegration Problem1
Patient problems
- Neuralgia1
- Osteolysis1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2024Material Discolored; Material Discolored
21-YEAR-OLD HEALTHY FEMALE HAD IMPLANTS PLACED IN THE UR1 AND UL 1 POSITIONS, WITHOUT ADDITIONAL BONE GRAFTING. A 15X25MM VOLUMAX WAS USED BUCCALLY TO THICKEN SOFT TISSUES. PATIENT STARTED TO GET A NEURALGIA TYPE PAIN FROM THE UL 1 IMPLANT (UR1 ABSOLUTELY FINE); THE DOCTOR HAD TO RE-ENTER AT 1 MONTH TO REMOVE THE LEFT IMPLANT. ON RE-ENTRY, THE VOLUMAX WAS FOUND TO BE NO LONGER AS ONE INTACT PIECE - IT WAS YELLOWISH AND SOFT LIKE GOO AND HAD LOST ITS DIMENSIONAL STABILITY. THE DOCTOR REMOVED THE VOLUMAX.
Patient problems: Neuralgia
MAUDE report 18862943 ↗InjuryFeb 10, 2023Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS FOLLOWING SEVERE SWELLING, INFECTION AND OSTEOLYSIS WHERE OSSIX VOLUMAX WAS PLACED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16359088 ↗
Other Barrier, Animal Source, Intraoral devices
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- Neomem N1520Collagen Matrix, Inc. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-226Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-342Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-306Benco Dental Supply CO. · 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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