OSSIX® PLUS OXP3040Recalls & reported problems
Datum Dental Ltd · Resorbable collagen membrane · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290015477710), received between Jul 25, 2018 and Jul 25, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2018Improper or Incorrect Procedure or Method
A DENTIST REPORTED THAT TWO OSSIX PLUS MEMBRANES APPEARED SMALLER THAN SPECIFIED ON THE LABELLING. ACCORDING TO THE DENTIST, 1ST ITEM MEASURED 29 X 34 MM AND 2ND ITEM MEASURED 29 X 35 MM, WHILE SPECIFIED AS 30 X 40 MM. THE MEASUREMENTS WERE TAKEN ON DRY, PRIOR TO HYDRATION, MEMBRANES. TWO HUFRIEDY UNC 15 PERIODONTAL PROBES WERE USED TO MEASURE THE MEMBRANES. THE DENTIST DID NOT USE THESE TWO MEMBRANES AND USED A THIRD MEMBRANE INSTEAD. THE PATIENT ANESTHESIA TIME WAS EXTENDED. THE PRODUCT'S IFU INSTRUCTS THAT OSSIX PLUS SHOULD BE IMMERSED FOR 30 SECONDS IN STERILE SALINE, TO ALLOW FOR ITS EXPANSION TO ITS FINAL DIMENSIONS (15X25 MM, 25X30 MM, 30X40 MM).
Patient problems: No Code Available
MAUDE report 7721283 ↗
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
- 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.