XLIF 6940429Recalls & reported problems
Nuvasive, Inc. · XLIF Pituitary, Small · Class 1 · Implant
All models of XLIF (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nuvasive XLIF pituitary is a manual orthopedic surgical instrument. The 23 reports that name its identifier mostly describe the tip breaking off during surgery, with the broken piece retrieved from the patient. There were no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00887517452764), received between Sep 9, 2022 and Jan 8, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Fracture” (23 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
- Fracture23
Patient problems
- No Clinical Signs, Symptoms or Conditions23
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗MalfunctionMar 31, 2025Fracture; Fracture
DURING A PROCEDURE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21732493 ↗MalfunctionNov 22, 2024Fracture; Fracture
DURING A PROCEDURE, THE DISTAL ARTICULATING TIP OF A PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20762922 ↗MalfunctionNov 21, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20747732 ↗MalfunctionJul 10, 2024Fracture; Fracture
DURING A PROCEDURE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19713818 ↗MalfunctionJun 12, 2024Fracture; Fracture
DURING A PROCEDURE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19520102 ↗MalfunctionMay 22, 2024Fracture; Fracture
DURING A PROCEDURE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19374578 ↗MalfunctionJan 12, 2024Fracture; Fracture
IT WAS REPORTED THE PITUITARY RONGEUR TIP FRACTURED OFF WHEN TRYING TO REMOVE BONE. REPORTEDLY, THE SURGEON STATED THE EVENT WAS NOT THE FAULT OF THE INSTRUMENT. THE FRACTURED PORTION WAS RETRIEVED FROM THE PATIENT. THERE WAS NO REPORT OF ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18508320 ↗MalfunctionOct 3, 2023Fracture; Fracture
MalfunctionMay 31, 2023Fracture; Fracture
IT WAS REPORTED THE INSTRUMENT TIP FRACTURED OFF DURING PROCEDURE. THE BROKEN PART WAS RECOVERED. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17035092 ↗MalfunctionMay 23, 2023Fracture; Fracture
ON (B)(6) 2023 A PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE USING A LATERAL APPROACH ON UNKNOWN LEVELS OF THE SPINE. DURING THE PROCEDURE WHILE REMOVING DISC TISSUE THE DISTAL BITING JAW FRACTURED OFF IN THE PATIENT AND WAS RETRIEVED FROM THE DISC SPACE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16986349 ↗MalfunctionApr 17, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE. DURING THE PROCEDURE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16758654 ↗MalfunctionApr 6, 2023Fracture; Fracture
DURING A SPINAL PROCEDURE THE TIP OF THE DEVICE BROKE OFF. IT IS UNKNOWN IF THE TIP WAS RETRIEVED OR LEFT IN-SITU AS NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16694001 ↗MalfunctionApr 6, 2023Fracture; Fracture
DURING A SPINAL PROCEDURE THE TIP OF THE DEVICE BROKE OFF. IT IS UNKNOWN IF THE TIP WAS RETRIEVED OR LEFT IN-SITU AS NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16693991 ↗MalfunctionMar 22, 2023Fracture; Fracture
ON (B)(6) 2023 DURING A SPINAL PROCEDURE, THE TOP BITING TIP OF THE PITUITARY BROKE DURING USE. ALL FRAGMENTS WERE RETRIEVED AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16593420 ↗MalfunctionMar 1, 2023Fracture; Fracture
ON (B)(6) 2023 DURING A SPINAL PROCEDURE THE TIP OF PITUITARY FRACTURED OFF. ALL PIECES WERE RETRIEVED AND THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16463209 ↗MalfunctionFeb 7, 2023Fracture; Fracture
ON (B)(6) 2023 A PATIENT UNDERWENT A ANTERIOR CORPECTOMY PROCEDURE FROM L1 TO L3. IT WAS REPORTED THAT THE PATIENT HAD DIFFICULT ANATOMY FOR THE SURGERY AND WAS LARGER IN SIZE. DURING THE PROCEDURE THE UPPER BITING JAW OF THE DEVICE FRACTURED OFF WHILE REMOVING TISSUE AT THE L2 LEVEL AND WAS IMMEDIATELY RETRIEVED FROM THE PATIENT. NO ADVERSE PATIENT CONSEQUENCE OR SURGICAL DELAYS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16312704 ↗MalfunctionNov 22, 2022Fracture; Fracture
CORRECT AND UPDATED INFORMATION LISTED IN SECTION H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15847606 ↗MalfunctionNov 21, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EXTREME LATERAL INTERBODY FUSION. DURING THE PROCEDURE, AS THE SURGEON WAS PERFORMING A DISCECTOMY AT THE L3/L4 DISC SPACE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15840593 ↗MalfunctionSep 9, 2022Fracture; Fracture
ON (B)(6) 2022, DURING A SPINAL PROCEDURE THE TOP PITUITARY TIP BROKE OFF. THE PIECES WERE RETRIEVED AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15396657 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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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