OsteoCool Bone Access Kits OCN002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000027049), received between May 24, 2019 and May 24, 2019 — 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 16, 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.

• MalfunctionMay 24, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE PREOPERATIVE DIAGNOSIS OF PAINFUL BREAST METASTATIC LESION AT T11; AND UNDERWENT A SURGERY. INTRA-OP, THE PLASTIC WING OF THE CANNULA SEPARATED FROM THE CANNULA OF THE MAPPING INSTRUMENTS. THE BONE WAS EXTREMELY HARD AND A LOT OF HEAVY MALLETING WAS NEEDED TO GAIN TROCAR ACCESS IN THIS OSTEOBLASTIC BREAST LESION. THE TROCAR WAS REMOVED FROM THE VERTEBRAL BODY WITH A COKER CLAMP AND MALLET TO GAIN LEVERAGE IN ORDER TO GET THE CANNULA OUT OF THE PATIENT. A NEW TROCAR WAS USED IN THE SAME HOLE AND THE PROCEDURE WAS COMPLETED WITH NO PROBLEMS. NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. THERE WAS A DELAY OF 15 MINUTES IN OVERALL PROCEDURE TIME DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8639787 ↗