CoRoent 6121023Recalls & reported problems
Nuvasive, Inc. · CoRoent® Large MP, 10x9x23 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 00887517289049), received between Mar 8, 2017 and Mar 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Problem” (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
- Positioning Problem1
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 8, 2017Positioning Problem; Positioning Problem
ON (B)(6) 2017 A (B)(6) YO FEMALE UNDERWENT A POSTERIOR BI-LATERAL LUMBAR INTERBODY FUSION AT L4-5 SPINE LEVEL. DURING IMPACTION OF THE LEFT SIDE INTERBODY DEVICE WAS PUSHED ANTEROLATERALLY PAST THE VERTEBRAL MARGIN INTO THE RETROPERITONEAL SPACE. SURGEON DISCRETION WAS TO LEAVE THE MALPLACED INTERBODY DEVICE IN-SITU AND COMPLETED THE PROCEDURE WITH AN ADDITIONAL INTERBODY DEVICE WITHOUT FURTHER COMPLICATION. A REVISION SURGERY WAS PLANNED AND SCHEDULED. NO PATIENT INJURY WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 6390090 ↗
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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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