XLIF 6940430Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00887517452771), received between Jun 3, 2022 and Feb 24, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 5, 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 20856139 ↗
• MalfunctionJul 17, 2024Fracture; Fracture

  DURING AN EXTREME LATERAL 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 19767479 ↗
• 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 19519725 ↗
• MalfunctionMar 14, 2024Fracture; Fracture

  IT WAS REPORTED THE TIP OF PITUITARY RONGEUR FRACTURED OFF IN THE DISC SPACE DURING A PROCEDURE. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909503 ↗
• MalfunctionDec 6, 2023Fracture; Fracture

  IT WAS REPORTED THE PITUITARY TIP FRACTURED OFF DURING A PROCEDURE WHILE REMOVING AN OSTEOPHYTE. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275406 ↗
• MalfunctionNov 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE JAW FRACTURED OFF DURING PROCEDURE. THE BROKEN PART WAS RECOVERED AND DISCARDED. THERE WAS NO REPORT OF ADVERSE PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167306 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993007 ↗
• MalfunctionMay 17, 2023Fracture; Fracture

  DURING A SPINAL PROCEDURE THE TEETH WERE BROKEN AND EVERYTHING WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946420 ↗
• MalfunctionApr 4, 2023Fracture; Fracture

  DURING A SPINAL PROCEDURE THE DISTAL GRABBING FEATURE BROKE AND THE SEPARATED PIECE WAS RETRIEVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675183 ↗
• MalfunctionFeb 27, 2023Fracture; Fracture

  ON (B)(6) DURING A SPINAL PROCEDURE IT WAS REPORTED THAT THE TOP OF THE PITUITARY BROKE OFF. ALL PIECES WERE RETRIEVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448953 ↗
• MalfunctionNov 22, 2022Fracture; Fracture

  ON (B)(6) 2022 A PATIENT UNDERWENT A BILATERAL POSTERIOR LATERAL INTERBODY FUSION REVISION PROCEDURE FROM L5-S1 TO ADDRESS RETROPULSION. THE DEVICES BEING REVISED WERE NOT NUVASIVE PRODUCTS. WHILE REMOVING THE CAGE THE UPPER DISTAL JAW OF TWO DEVICES FRACTURED. THE FRACTURED PIECES WERE REMOVED FROM THE PATIENT. THERE WERE NO INJURIES OR ADVERSE PATIENT CONSEQUENCES AND THE SURGERY WAS COMPLETED WITHOUT ISSUE. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849175 ↗
• MalfunctionJun 3, 2022Fracture; Fracture

  ON (B)(6) 2022 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FIXATION PROCEDURE. DURING THE PROCEDURE WHILE REMOVING TISSUE FROM THE DISC SPACE THE UPPER DISTAL BITING JAW FRACTURED OFF. ALL PIECES WERE RETRIEVED WITHOUT INJURY OR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594371 ↗