NuVasive 6911101Recalls & reported problems
Nuvasive, Inc. · Uni Inserter, CoRoent XL Dismantlable · Class 1
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 00887517391704), received between Apr 19, 2024 and Mar 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE DISTAL, THREADED TIP, OF THE DEVICE FRACTURED OFF INTO THE ENGAGED IMPLANT AND COULD NOT BE RETRIEVED. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 21668695 ↗MalfunctionJul 17, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TRIAL INSERTER TIP FRACTURED OFF INSIDE THE TRIAL. THE FRACTURED PORTION WAS RETRIEVED WITH THE TRIAL AND NO FRAGMENT WAS LEFT IN-SITU. THERE WAS NO REPORTED IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19767331 ↗MalfunctionApr 19, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TRIAL INSERTER TIP FRACTURED OFF INSIDE THE TRIAL. THE FRACTURED PORTION WAS RETRIEVED ALONG WITH THE TRIAL AND NO FRAGMENT WAS LEFT IN-SITU. THERE WAS NO REPORTED IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19149012 ↗
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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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