CoRoent 5181308P2Recalls & reported problems
Nuvasive, Inc. · CoRoent Ant TLIF PEEK, 8x11x30mm 8° · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517733009), received between Nov 23, 2021 and Sep 30, 2022 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture2
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
UPDATED INFORMATION LISTED IN SECTION H10.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15520168 ↗MalfunctionNov 23, 2021Fracture; Fracture
ON (B)(6) 2021 A TRANSFORAMINAL LUMBAR INTERBODY FUSION WAS PERFORMED AT L3/5. ON (B)(6) 2021 THE PATIENT REPORTED PAIN AND RADIOGRAPHS REVEALED A PEDICLE FRACTURE AT L5 AND SPONDYLOLISTHESIS OF L5/S CAUSED BY L5 PEDICLE FRACTURE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED AND SCREWS WERE ADDED TO S1 AND S2. NO ADDITIONAL INJURIES WERE REPORTED.
Patient problems: Pain
MAUDE report 12863745 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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