RegenerOss Resorbable Xenograft ROXR05Recalls & reported problems
Collagen Matrix, Inc. · Porcine Anorganic Bone Mineral · Class 2 · Implant
All models of RegenerOss Resorbable Xenograft (2)
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 00813954022338), received between Oct 18, 2019 and Oct 18, 2019 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Inadequate Osseointegration2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CLINICIAN USED THE PORCINE XENOGRAFT ALONG WITH PUROS PARTICULATE ALLOGRAFT AND A BIOMEND ABSORBABLE COLLAGEN MEMBRANE. THE PATIENT RETURNED AFTER 5 MONTHS FOR IMPLANT PLACEMENT. THE CLINICIAN REPORTED TO BE UNHAPPY WITH THE OUTCOME OF THE BONE AUGMENTATION AND THE IMPLANT WAS UNABLE TO BE PLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 9208317 ↗InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CLINICIAN USED THE PORCINE XENOGRAFT ALONG WITH PUROS PARTICULATE ALLOGRAFT AND A BIOMEND ABSORBALE COLLAGEN MEMBRANE. THE PATIENT RETURNED AFTER 5 MONTHS FOR IMPLANT PLACEMENT. THE CLINICIAN REPORTED TO BE UNHAPPY WITH THE OUTCOME OF THE BONE AUGMENTATION AND THE IMPLANT WAS UNABLE TO BE PLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 9208314 ↗
Other Bone Grafting Material, Animal Source devices
- RegenerOss Resorbable Xenograft ROXR40Collagen Matrix, Inc. · Bone Grafting Material, Animal Source1 recall1 report
- NuOss 5091003Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE1 recall0 reports
- Gibson Healthcare® Bone Graft Plug 5824-413Collagen Matrix, Inc. · Bone Grafting Material, Animal Source6 reports
- OSSIX™ Bone 0.250 ccDatum Dental Ltd · Bone Grafting Material, Animal Source5 reports
- NuOss 5091004Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE5 reports
- PreservaRidge™ Plug PRPREGCollagen Matrix, Inc. · Bone Grafting Material, Animal Source3 reports
- NuOss 5099100Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE3 reports
- NuOss 5099002Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE3 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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