CoRoent 6020001Recalls & reported problems
Nuvasive, Inc. · CoRoent Large MP Inserter, Large · Class 2
All models of CoRoent (64)
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 00887517278050), received between Mar 29, 2017 and Mar 29, 2017 — 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
- Device Slipped1
- Migration or Expulsion of Device1
- Unintended Movement1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2017Break; Migration or Expulsion of Device; Device Slipped; Unintended Movement; Break; Migration or Expulsion of Device; Device Slipped; Unintended Movement
ON (B)(6) 2017 A (B)(6) MALE PATIENT UNDERWENT A POSTERIOR DISCECTOMY AND FUSION PROCEDURE. DURING THE PROCEDURE THE STEEL SHEATH ON THE INSERTER REPORTEDLY FRACTURED. AS A RESULT THE IMPLANT WOULD NOT ROTATE TO THE PROPER ORIENTATION CAUSING IT TO DISENGAGE FROM THE INSERTER. THE ATTEMPTS TO MOVE/PLACE THE IMPLANT LED TO ANTERIOR MIGRATION INTO THE PERITONEUM. ON (B)(6) 2017 THE PATIENT UNDERWENT A DIAGNOSTIC LAPROSCOPY FOR RETRIEVAL OF THE MIGRATED IMPLANT. THE PATIENT IS RECOVERING WELL POST-REOPERATION.
Patient problems: Foreign Body In Patient
MAUDE report 6443766 ↗
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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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