NuOss 5091004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00614950007271), received between Jan 10, 2018 and Jan 10, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE.

  Patient problems: Complaint, Ill-Defined; Inadequate Osseointegration

  MAUDE report 7178438 ↗
• InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE. ADDITIONALLY, THE PATIENT PRESENTED WITH UNRESOLVED SUBMANDIBULAR GLAND LYMPHADENOPATHY AND FLOOR OF MOUTH SWELLING AND WAS REFERED TO ENT PHYSICIAN.

  Patient problems: Inadequate Osseointegration; Inflammation

  MAUDE report 7178437 ↗
• InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE.

  Patient problems: Complaint, Ill-Defined; Inadequate Osseointegration

  MAUDE report 7178436 ↗
• InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE.

  Patient problems: Complaint, Ill-Defined; Inadequate Osseointegration

  MAUDE report 7178432 ↗
• InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE.

  Patient problems: Complaint, Ill-Defined; Inadequate Osseointegration

  MAUDE report 7178425 ↗