NuVasive 6904485Recalls & reported problems
Nuvasive, Inc. · Universal Inserter, XLIF Angled · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517389091), received between Sep 18, 2023 and Dec 29, 2025 — classified as 1 injury, 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. 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
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT XLIF TRIAL WITH INSERTER PASSED THROUGH TO THE OPPOSITE SIDE AT INTERVERTEBRAL SPACE OF L4/L5 LEVEL. THE SURGEON STRUCK XLIF INSERTER HARDLY WHILE INSERTING A TRIAL INTO THE INTERVERTEBRAL SPACE AT THE L4/L5 LEVEL SINCE IT WAS NARROW. BLEEDING OCCURRED WHEN THE SURGEON REMOVED THE TRIAL WITH INSERTER, AND THE PATIENT¿S BLOOD PRESSURE DROPPED. AFTER COMPRESSION HAEMOSTASIAS, BLOOD PRESSURE RECOVERED TO NORMAL LIMITS WITHIN APPROXIMATELY ONE MINUTE. AFTER CONFIRMING SUCCESSFUL HAEMOSTASIAS, THE SURGEON INSERTED SPINAL CAGES INTO THE L3~L5 INTERVERTEBRAL SPACE BY XLIF, AND FIXED SPINE BY POSTERIOR SPINAL FIXATION AND CLOSED THE SURGERY. THERE WAS NO FLUCTUATION IN THE MOTOR-EVOKED POTENTIAL (MEP) BLOOD TRANSFUSIONS WERE ALSO NOT ADMINISTERED. NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 23917073 ↗MalfunctionDec 4, 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 20848720 ↗InjurySep 18, 2023Fracture; Fracture
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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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