CoRoent 7151260Recalls & reported problems
Nuvasive, Inc. · CoRoent XLW 15°, 12x22x60mm · Class 2 · Implant
All models of CoRoent (64)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517231796), received between May 22, 2020 and Jul 19, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Post Operative Wound Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2024Fracture; Fracture
ON (B)(6) 2024 A PATIENT UNDERWENT A LATERAL INTERBODY FUSION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. DURING INSERTION OF THE VERTEBRAL SPACER IT FRACTURED. THE FRACTURED PORTIONS WERE RETRIEVED FROM THE PATIENT AND THE REMAINDER OF THE IMPLANT REMAINS IN SITU. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19784421 ↗InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2020 A PATIENT UNDERWENT A LUMBAR FUSION SPINAL PROCEDURE. POSTOPERATIVELY, THE PATIENT DEVELOPED A SUPERFICIAL WOUND INFECTION. PATIENT WAS TREATED WITH IV ABX AND UNDERWENT I&D (INCISION AND DEBRIDEMENT).
Patient problems: Post Operative Wound Infection
MAUDE report 10084330 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- 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
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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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