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NuOss 5099100Recalls & reported problems

Ace Surgical Supply CO., Inc. · NUOSS COLLAGEN 6X7X8MM APPROXIMATELY 100MG · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00614950007493), received between Feb 5, 2021 and Feb 5, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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

Device problems

  • Adverse Event Without Identified Device or Use Problem3
  • Insufficient Device Problem Information3

Patient problems

  • Post Operative Wound Infection3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    THE CUSTOMER REPORTED THAT THEY HAD A PATIENT THAT WAS PRESENTED WITH PAIN, REDNESS, AND SWELLING IN THE AREA AFTER SURGERY. REVISION INCLUDED RE-ENTERING THE SURGICAL SITE, REMOVING THE INFECTED TISSUE, BONE, AND BIOCERAMIC PUTTY, THOROUGHLY CLEANING THE AREA WITH CHLORHEXIDINE GLUCONATE. PLACING NEW BIOCERAMIC PUTTY IN THE TOOTH ACCESS, PLACING NEW BONE, AND CLOSING THE SITE WITH SUTURE. PATIENTS WERE PLACED ON AN ANTIBIOTIC AND CHLORHEXIDINE GLUCONATE REGIMEN 2 DAYS PRIOR TO TREATMENT AND 5 DAYS FOLLOWING TREATMENT.

    Patient problems: Post Operative Wound Infection

    MAUDE report 11286359 ↗
  • InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    THE CUSTOMER REPORTED THAT THEY HAD A PATIENT THAT WAS PRESENTED WITH PAIN, REDNESS, AND SWELLING IN THE AREA AFTER SURGERY. REVISION INCLUDED RE-ENTERING THE SURGICAL SITE, REMOVING THE INFECTED TISSUE, BONE, AND BIOCERAMIC PUTTY, THOROUGHLY CLEANING THE AREA WITH CHLORHEXIDINE GLUCONATE. PLACING NEW BIOCERAMIC PUTTY IN THE TOOTH ACCESS, PLACING NEW BONE, AND CLOSING THE SITE WITH SUTURE. PATIENTS WERE PLACED ON AN ANTIBIOTIC AND CHLORHEXIDINE GLUCONATE REGIMEN 2 DAYS PRIOR TO TREATMENT AND 5 DAYS FOLLOWING TREATMENT.

    Patient problems: Post Operative Wound Infection

    MAUDE report 11286357 ↗
  • InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    THE CUSTOMER REPORTED THAT THEY HAD A PATIENT THAT WAS PRESENTED WITH PAIN, REDNESS, AND SWELLING IN THE AREA AFTER SURGERY. REVISION INCLUDED RE-ENTERING THE SURGICAL SITE, REMOVING THE INFECTED TISSUE, BONE, AND BIOCERAMIC PUTTY, THOROUGHLY CLEANING THE AREA WITH CHLORHEXIDINE GLUCONATE. PLACING NEW BIOCERAMIC PUTTY IN THE TOOTH ACCESS, PLACING NEW BONE, AND CLOSING THE SITE WITH SUTURE. PATIENTS WERE PLACED ON AN ANTIBIOTIC AND CHLORHEXIDINE GLUCONATE REGIMEN 2 DAYS PRIOR TO TREATMENT AND 5 DAYS FOLLOWING TREATMENT.

    Patient problems: Post Operative Wound Infection

    MAUDE report 11286350 ↗

Other BONE GRAFTING MATERIAL, ANIMAL SOURCE devices

All BONE GRAFTING MATERIAL, ANIMAL SOURCE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.