CoRoent 6921250Recalls & reported problems
Nuvasive, Inc. · CoRoent® XL Wide, 12x22x50mm Lordotic · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517394118), received between Mar 29, 2018 and Mar 29, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Discomfort1
- Numbness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2018 PATIENT UNDERWENT A TWO LEVEL EXTREME LATERAL INTERBODY FUSION. REPORTEDLY WHILE INSERTING THE CAGE AT L4/5 LEVELS, THE CAGE WAS PLACED TOO ANTERIOR (PAST THE ANTERIOR LONGITUDINAL LIGAMENT), THE CAGE WAS REMOVED AND BONE GRAFT WAS PLACED WITHIN THE DISC SPACE. AFTER PLACING A CAGE AT THE SECOND LEVEL L3/4 AN X-RAY NOTED CAGE WAS PLACED TOO POSTERIOR HOWEVER THE SURGEONS CONCURRED TO LEAVE THE CAGE AS PLACED AND CONTINUE TO MONITOR PATIENT. PATIENT WAS REPORTED TO HAVE FULL POWER IN LEGS AND WAS TRANSFERRED TO THE WARD FOR RECOVERY. DURING THE NIGHT PATIENT EXPERIENCED DISCOMFORT AND STARTED TO LOOSE SENSATION/POWER IN HER LEGS. AN MRI WAS CARRIED OUT NEXT MORNING AND PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE CAGE WAS REMOVED AND DECOMPRESSION WAS PERFORMED. PATIENT IS REPORTED TO BE ATTENDING REHAB FOR HER LEGS.
Patient problems: Discomfort; Numbness
MAUDE report 7382753 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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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