OSTEOCOOL KIT BONE ACCESS 10G 090 OCN002Recalls & reported problems
Medtronic Sofamor Danek, Inc. · KIT OCN002 OSTEOCOOL BONE ACCESS 10G 090 · 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 00763000311780), received between Jul 13, 2021 and Jul 13, 2021 — 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
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2021Break; Break
ADDITIONAL INFORMATION WAS RECEIVED, REGARDING THE EVENT. IT WAS REPORTED, THAT THE THERAPY INVOLVED IS RF ABLATION. AND THE TOTAL PROCEDURE TIME WAS ABOUT 3 HOURS. WHICH IS MUCH LONGER THAN A TYPICAL CASE LIKE THIS. IT STILL HAS NOT BEEN DETERMINED, IF THE METAL FRAGMENTS WILL BE RETRIEVED AT SOME POINT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12156920 ↗
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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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