OsteoCool Bone Access Kits OCN005Recalls & reported problems
Medtronic Sofamor Danek, Inc. · KIT OCN005 OSTEOCOOL BONE ACCESS 13G 100 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000027070), received between Dec 8, 2020 and Dec 8, 2020 — 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
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2020Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT HANDLE BROKE OFF WHEN TRYING TO TAKE NEEDLE OUT OF THE SACRUM. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE THERAPY INVOLVED IN THE EVENT WAS OSTEOCOOL OF THE SACRUM. HANDLE BROKE OFF OF THE CANULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10966736 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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