OSTEOCOOL BONE ACC 10G 090 OCN002HBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000600167), received between Apr 18, 2026 and Apr 18, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY THE RAPY. IT WAS REPORTED THAT THE PATIENT HAD DENSE SCLEROTIC BONE AND THE PHYSICIAN USED A MALLET TO ADVANCE THE HAND DRILL TO THE TARGET LOCATION. WHEN THE PHYSICIAN REMOVED THE HAND DRILL, IT WAS OBSERVED THAT THE DRILL TIP HAD BROKEN DURING MALLEATING AND REMAINED IN THE VERTEBRAL BODY. IT WAS FURTHER REPORTED THAT THE RETAINED DRILL TIP WAS AT THE KYPHOPLASTY LOCATION AND WAS SUBSEQUENTLY ENCASED IN A BOLUS OF CEMENT. THE PHYSICIAN ALLEGED THAT HAMMERING/MALLEATING THE DEVICE CAUSED THE DRILL TIP TO BREAK AND IT WAS ENCASED IN A BOLUS OF CEMENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24919415 ↗