RegenerOss Resorbable XenograftRecalls & reported problems across all models

We found 2 models of RegenerOss Resorbable Xenograft by Collagen Matrix, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2019 and Oct 18, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

RegenerOss Resorbable Xenograft recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 30, 2018Terminated

   There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.

   Z-0752-2019 · Root cause: Employee error · Recall details · FDA record ↗

Most reported RegenerOss Resorbable Xenograft problems

RegenerOss Resorbable Xenograft models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RegenerOss Resorbable Xenograft ROXR40

  Bone Grafting Material, Animal Source
  1 recall1 report
• RegenerOss Resorbable Xenograft ROXR05

  Bone Grafting Material, Animal Source
  2 reports

Recent RegenerOss Resorbable Xenograft adverse event reports

The 3 most recent reports across all models, 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 ↗
• InjurySep 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CLINICIAN REPORTED HAVING ADVERSE EVENTS THAT THEY HAVE NOT SEEN IN THE PAST. THESE ADVERSE EVENTS INCLUDE BONE LOSS, DELAYED HEALING AND INFLAMMATION. IT IS UNKNOWN HOW THE CLINICIAN CIRCUMVENTED THE ISSUES.

  Patient problems: Inflammation; No Code Available

  MAUDE report 9106059 ↗

Other Collagen Matrix, Inc. products

• DuraMatrix Onlay3 models · 7 reports · 1 recall
• DuraMatrix Suturable5 models · 37 reports