OSTEOCOOL KIT BONE ACCESS 13G 100 OCN005Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000311810), received between Aug 26, 2021 and Sep 28, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROFESSIONAL) REGARDING A PATIENT HAVING VERTEBROPLATY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT SURGEON ADVANCED BOTH NEEDLES FURTHER INTO THE BONE THEN HOOKED THE CEMENT CARTRIDGES DIRECTLY TO THE ACCESS NEEDLES.  THIS WORKED WELL, HOWEVER WHEN PULLING ONE OF THE NEEDLES OUT, SURGEON FELT A SNAP AND THE PLASTIC HUB OF ONE NEEDLE BROKE.  THE PLASTIC PART THEN SPUN FREELY WITHOUT MOVING THE METAL PORTION OF THE NEEDLE.   THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500995 ↗
• MalfunctionMar 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT RADIO FREQUENCY ABLATION (RFA) SPINAL THERAPY. IT WAS REPORTED THAT THE UPPERCUT PART OF THE TROCAR HAS SEPARATED. WHEN THE SURGEON WANTED TO REMOVE THE TROCAR, IT WAS NOT POSSIBLE AND HE HAD TO USE PLIERS WHICH DAMAGED THE INSTRUMENT. THE PATIENT HAD RETURNED TO HOSPITAL TO UNDERGO AN INTERVENTION AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO DELAY IN SURGICAL PROCEDURE AND BROKEN FRAGMENTS LEFT INSIDE THE PATIENT. THERE WAS NO ADDITIONAL SURGERY WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926198 ↗
• MalfunctionMar 23, 2022Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING SPINAL THERAPY FOR BONE TUMOR. IT WAS REPORTED THAT TROCARS GOT STUCK IN HARD BONE AND WERE TOUGH TO REMOVE. WHILE PULLING REMOVING THE TROCAR, THE HUB PULLED OFF COMPLETELY LEAVING JUST THE METAL PART OF TROCAR WITH NOTHING TO GRAB INTO. THE PHYSICIAN WAS ULTIMATELY ABLE TO REMOVE THE TROCARS WITH PLIERS AND NO HARM WAS DONE TO THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARD ING THE EVENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PRODUCT WAS DISCARDED. THERE WAS A DELAY LESS THAN 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13859834 ↗
• MalfunctionMar 22, 2022Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PLASTIC HANDLE ON THE TOP OF THE CANULA GET DETACHED AND THE SURGEON STRUGGLED TO GET THE CANULA OUT OF THE PATIENT. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND SURGERY WAS COMPLETED WITHOUT OTHER ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13853007 ↗
• InjuryDec 2, 2021Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH PAINFUL OSTEOID OSTEOMA. IT WAS REPORTED THAT WHILE DRILLING THROUGH THE THICK CORTEX, HCP TRIED TO REVERSE DRILL OUT OF BONE BECAUSE IT WOULD NOT ADVANCE, THE DRILL TIP SHEARED OFF AND WAS LEFT BEHIND STUCK IN THE TIBIA. A REVISION SURGERY WILL BE SCHEDULED TO REMOVE THE DRILL TIP. NO OTHER PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12914590 ↗
• MalfunctionAug 26, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PROBE NEEDLE BECAME STUCK IN THE PATIENT AS THE HEAD OF THE CANNULA LUMEN COMPLETELY CAME OFF THE CANNULA. STERILE FORCEPS WERE USED TO REMOVE IT FROM THE PATIENT. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT IT WAS NOT THE TIP BUT JUST THE CANNULA AS IT WAS THE HANDLE OF THE CANNULA THAT CAME OFF. THERE WERE NO PATIENT COMPLICATIONS OR ADDITIONAL SURGERY. WE USED STERILE FORCEPS TO REMOVE IT & THERE WAS NO ADDITIONAL SURGERY TIME ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369243 ↗