CoRoent 6914260Recalls & reported problems
Nuvasive, Inc. · CoRoent® XL Wide, 14x22x60mm · 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 00887517392183), received between Nov 16, 2022 and Nov 16, 2022 — 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
- Bone Fracture(s)1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON A CLINICAL STUDY THAT ON (B)(6) 2022 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION AT L3/4. ON (B)(6) 2022 THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR LEFT SCIATIC PAIN. AN MRI SHOWED A COMPRESSION FRACTURE AT THE SUPERIOR ENDPLATE OF L3, NO APPARENT COMPLICATIONS OR DISLODGEMENT OF HARDWARE. AT L5-S1 THERE WAS LATERAL DISC HERNIATION INVOLVING IN COMPRESSING LEFT L5 NERVE ROOT. TREATMENT WAS PAIN BLOCK INJECTIONS.
Patient problems: Bone Fracture(s); Pain
MAUDE report 15807690 ↗
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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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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