CoRoent 5181304P2Recalls & reported problems
Nuvasive, Inc. · CoRoent Ant TLIF PEEK, 8x11x30mm 4° · 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 00887517896414), received between Jan 28, 2022 and Jan 28, 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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2021 A PATIENT UNDERWENT A POSTERIOR LATERAL INTERBODY FUSION PROCEDURE FROM L4-L5 WHERE A COMPETITOR RESORBABLE BONE REGENERATION MATERIAL WAS UTILIZED. THE PATIENT WAS RELEASE FROM THE HOSPITAL ON (B)(6) 2021 BUT IT WAS OBSERVED THE PATIENTS C-REACTIVE PROTEIN LEVELS WERE NOT DROPPING AND AS A CONSEQUENCE ANTIBIOTICS WERE ADMINISTERED. THE FIRST ROUND OF ANTIBIOTICS WERE FOLLOWED UP WITH ORAL ANTIBIOTICS THAT THE PATIENT STARTED TAKING ON (B)(6) 2021 AND DISCONTINUED ON (B)(6) 2021. THE PATIENT HAS DISCONTINUED THE ORAL ANTIBIOTICS AS THEY HAVE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13387484 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- 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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