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NuOss 5099002Recalls & reported problems

Ace Surgical Supply CO., Inc. · NUOSS CANCELLOUS .5GRAM/1.2CC PARTICLE SIZE .25-1.0MM · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00614950007431), received between Aug 30, 2018 and Aug 30, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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

  • Failure to Osseointegrate3

Patient problems

  • Failure of Implant3

Recent adverse event reports

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

  • MalfunctionAug 30, 2018Failure to Osseointegrate; Failure to Osseointegrate

    THE CLINICIAN REPORTED THAT THERE WAS NO BONE INTEGRATION FOLLOWING THE BONE GRAFT PROCEDURE. A FOLLOW-UP PROCEDURE WAS PERFORMED TO REMOVE THE PRODUCT AND RE-GRAFT THE SITE WITH ANOTHER BONE GRAFT PRODUCT WHICH RESULTED IN A 4-6 MONTH DELAY IN IMPLANT PLACEMENT.

    Patient problems: Failure of Implant

    MAUDE report 7834351 ↗
  • MalfunctionAug 30, 2018Failure to Osseointegrate; Failure to Osseointegrate

    THE CLINICIAN REPORTED THAT THE PATIENT UNDERWENT A BONE GRAFT PROCEDURE AND OBSERVED NO INTEGRATION. THE MATERIAL APPEARED DISCOLORED AND DARKER IN SHADE. NO INFECTION WAS OBSERVED. THE CLINICIAN PERFORMED A FOLLOW-UP PROCEDURE TO REMOVE THE ORIGINAL BONE GRAFT AND RE-GRAFTED THE SITE USING ANOTHER PRODUCT. THERE WAS A DELAY IN PLACEMENT OF IMPLANT 4 TO 6 MONTHS.

    Patient problems: Failure of Implant

    MAUDE report 7834348 ↗
  • MalfunctionAug 30, 2018Failure to Osseointegrate; Failure to Osseointegrate

    THE CLINICIAN REPORTED THAT THERE WAS NO BONE INTEGRATION FOLLOWING THE BONE GRAFT PROCEDURE. A FOLLOW-UP PROCEDURE WAS PERFORMED TO REMOVE THE PRODUCT AND RE-GRAFT THE SITE WITH ANOTHER BONE GRAFT PRODUCT WHICH RESULTED IN A 4-6 MONTH DELAY IN IMPLANT PLACEMENT.

    Patient problems: Failure of Implant

    MAUDE report 7834346 ↗

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.