OSSIX® PLUS OXP1525Recalls & 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 07290015477765), received between Mar 7, 2024 and Mar 7, 2024 — classified as 1 injury.
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
Patient problems
- Impaired Healing1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
67-YEAR-OLD FEMALE WHO HAS SLEEP APNEA AND OCCASIONALLY TAKES OMEPRAZOLE. REGULAR ATTENDER TO HYGIENIST AND PERIODONTIST. HAD AN IMMEDIATE ANTHOGYR IMPLANT PLACEMENT FOR THE UR1 WITH HORIZONTAL BONE AUGMENTATION USING PUROS ALLOGRAFT AND 15X25 OSSIX PLUS MEMBRANE STABILIZED WITH PERIOSTEAL SLING SUTURES. THE 2-WEEK STITCH REMOVAL WAS UNEVENTFUL, AND THE PATIENT HAD NO REPORTED PAIN OR SWELLING AT ANY STAGES DURING HEALING PHASE. AT THE 3-MONTH EXPOSURE APPOINTMENT, THERE WAS NO OBVIOUS PUS OR SINUS, BUT THE SOFT TISSUE HEALING WAS NOT GOOD AND AT EXPOSURE, SOFT TISSUE INFIL INTO THE GRAFT WAS DISCOVERED. THE IMPLANT WAS COMPROMISED, WITH SOME BONE LOSS AT THE HEAD OF THE IMPLANT.
Patient problems: Impaired Healing
MAUDE report 18862979 ↗
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.