CoRoent 6980850Recalls & reported problems
Nuvasive, Inc. · CoRoent® XL, 8x18x50mm 10° · Class 2 · Implant
All models of CoRoent (64)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517403209), received between Jan 13, 2021 and Dec 9, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
- Foreign Body Reaction1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Break; Fracture; Break; Fracture
NEW OR UPDATED INFORMATION LISTED ON H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20887129 ↗MalfunctionJan 27, 2023Fracture; Fracture
ON (B)(6) 2023 DURING A SPINAL PROCEDURE THE SURGEON ANNOUNCED THE IMPLANT HAD CRACKED WHILST INSERTING INTO THE DISC SPACE USING A HAMMER. THE IMPLANT PIECES WERE REMOVED AND THE REMAINDER OF THE CAGE PIECE WAS REMOVED FROM THE DISC SPACE WITH THE REMOVAL TOOL. ANOTHER CAGE WAS IMPLANTED. THE REMOVAL AND ALTERNATE CAGE BEING IMPLANTED RESULTED IN 5 MIN ADDITION TO SURGERY TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16257080 ↗MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NEW INFORMATION PROVIDED BY THE LEGAL TEAM VIA THE SURGEON ON 04/12/2021 HAS CORRECTED THE COMPLAINT DESCRIPTION BELOW: A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE ON (B)(6) 2020 DURING WHICH A LUMBAR INTER-BODY CAGE WAS MALPLACED TO ANTERIOR REQUIRING REMOVAL AND REPOSITIONING. THE INTERBODY CAGE WAS REMOVED FROM A PATIENT AND A TITANIUM LOCATION PIN WAS MISSING, A CT SCAN WAS PERFORMED AND REVEALED THE PIN WAS IN THE PATIENT'S LEFT PSOAS MUSCLE AND WOULD HAVE BEEN EXTREMELY DIFFICULT TO REMOVE. THE SURGEONS PREROGATIVE WAS TO LEAVE AS IS. NO REVISION HAS BEEN COMPLETED AT THIS TIME.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body Reaction
MAUDE report 11164640 ↗
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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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