CoRoent 6130823Recalls & reported problems
Nuvasive, Inc. · CoRoent Large MP Ti, 8x9x23mm 12° · Class 2 · Implant
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 00887517597137), received between Oct 14, 2021 and Oct 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2021Migration; Migration
ON (B)(6) 2021 A PATIENT UNDERWENT A MAS PROCEDURE FROM L5-S. DURING THE PROCEDURE TWO SPACER CAGES WERE PLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE FOLLOWING DAY A POST-OPERATIVE X-RAY CONFIRMED THE IMPLANTS HAD GOOD PLACEMENT. DURING A FOLLOW UP ON (B)(6) 2021 THE PATIENT REPORTED TO HAVE BEEN FEELING ONGOING PAIN. ANOTHER MRI OCCURRED WHICH SHOWED THE RIGHT SIDED CAGE HAD MIGRATED POSTERIOR AND WAS PROTRUDING. ON (B)(6) 2021 A REVISION CASE OCCURRED. DURING THE REVISION THE MIGRATED CAGE WAS REPLACED WITH A NEW ONE AND THE REST OF THE SURGERY WAS COMPLETED WITH NO ISSUE.
Patient problems: Pain
MAUDE report 12634163 ↗
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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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