XLIFRecalls & reported problems across all models
Nuvasive, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 53
- Deaths reported
- 1
- Injuries reported
- 7
- Recalls
- 0
We found 9 models of XLIF by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2018 and Mar 31, 2026 — classified as 1 death, 7 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Fracture” (45 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported XLIF problems
Device problems
- Fracture45
- Adverse Event Without Identified Device or Use Problem5
- Human-Device Interface Problem2
- Incorrect, Inadequate or Imprecise Result or Readings1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Hemorrhage/Blood Loss/Bleeding4
- Blood Loss1
- Damage to Ligament(s)1
- Great Vessel Perforation1
- Laceration(s)1
- Nerve Damage1
- Paralysis1
XLIF models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XLIF 6940429ORTHOPEDIC MANUAL SURGICAL INSTRUMENT23 reports
- XLIF 6940430ORTHOPEDIC MANUAL SURGICAL INSTRUMENT20 reports
- XLIF 6910220ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- XLIF 6914424ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death2 reports
- XLIF 5029950Orthopedic stereotaxic instrument1 report
- XLIF 6910222ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- XLIF 6940012ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- XLIF 6940018ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- XLIF 3230093ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent XLIF adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Fracture
IT WAS REPORTED THAT THE TOP PIECE OF THE XLIF COBB IS BROKEN. THERE IS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24747458 ↗MalfunctionFeb 24, 2026Fracture
THE CLOSING/ARTICULATING TIP OF THE PITUITARY BROKE DURING DISCECTOMY. THE TIP WAS RETRIEVED, AND NO HARM WAS DONE TO THE PATIENT. THE PROCEDURE WAS COMPLETED AS SCHEDULED REPLACING THE TLIF INTERBODY CAGE WITH A COHERE ALIF INTERBODY CAGE. THE PATIENT WAS DISCHARGED NORMALLY AND IS REPORTED TO BE DOING VERY WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433244 ↗MalfunctionFeb 20, 2026Fracture
IT WAS REPORTED THAT THE XLIF PITUITARY BROKE DURING SURGERY. IT WAS CONFIRMED NO PIECES OF THE INSTRUMENT FELL INTO THE PATIENT. THERE WAS NO ADVERSE EFFECT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405660 ↗MalfunctionFeb 4, 2026Fracture
THE TIP OF MEDIUM SIZED XLIF PITUITARY BROKE OFF DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24260970 ↗MalfunctionFeb 3, 2026Fracture
IT WAS REPORTED THAT THE HEAD OF PITUITARY BROKE OFF DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251439 ↗MalfunctionJan 8, 2026Fracture
IT WAS REPORTED THAT TWO XLIF PITUITARY INSTRUMENTS WERE FRACTURED WHEN TRYING TO REMOVE PLIF CAGES IN A REVISION XLIF. IT WAS CONFIRMED THAT ALL PARTS OF XLIF INSTRUMENTS WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004403 ↗InjuryJan 7, 2026Human-Device Interface Problem
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
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23989287 ↗MalfunctionDec 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TOP BITING PORTION OF THE PITUITARY BROKE OFF DURING A CASE. THE PIECE WAS RECOVERED AND THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23803038 ↗MalfunctionOct 20, 2025Fracture; Fracture
THE TIP OF THE PITUITARY INSTRUMENT WAS FRACTURED DURING SURGERY AND RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23335122 ↗MalfunctionSep 30, 2025Fracture; Fracture
THE DEVICE TIP WAS FRACTURED DURING SURGERY. THE TIP WAS RETRIEVED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23181318 ↗InjurySep 22, 2025Human-Device Interface Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHILE USING A XLIF COBB THE INSTRUMENT SLIPPED AND NICKED AN ARTERY CAUSING BLEEDING THAT THERE WAS INTERVENTION TO ADDRESS. THE SURGEON ARRESTED BLEEDING BY PACKING AND HEMOSTATIC AGENT.ON (b)(6) 2025 THE SURGEON CONFIRMED WITH A CT SCAN THAT THERE WERE NO HEMATOMA OR OTHER ABNORMALITIES. NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 23116236 ↗MalfunctionSep 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A XLIF PITUITARY BROKE OFF DURING SURGERY AND WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018048 ↗MalfunctionAug 25, 2025Fracture; Fracture
THE PITUITARY MOUTH BROKE OFF WHILE TRYING TO DO DISCECTOMY. ALL PARTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882803 ↗MalfunctionAug 25, 2025Fracture; Fracture
THE TIP BROKE OFF. SURGERY WAS ABLE TO CONTINUE ON WITHOUT ANY PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882747 ↗MalfunctionApr 17, 2025Fracture; Fracture
FRACTURED TIP WOULD NOT FUNCTION DURING EXTREME LATERAL INTERBODY FUSION, NO FRAGMENTS IN PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861943 ↗
Other Nuvasive, Inc. products
All Nuvasive, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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