XIA II 03821640Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540149237), received between Oct 3, 2016 and Apr 14, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2021Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING ROTATION OF THE XIA LL POLYAXIAL SCREW THE TULIP HEAD OF THE SCREW CAME OUT OF THE SHAFT INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES WERE REPORTED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 10 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667374 ↗
• MalfunctionApr 2, 2018Fracture; Break; Crack; Fracture

  IT WAS REPORTED THAT THE PATIENT NOTIFIED THE SURGEON OF SUDDEN ONSET OF AXIAL BACK PAIN. SURGEON TOOK X-RAYS, AND NOTICED SCREWS AT SR1 WERE BROKEN AND THE CAGE LOOKED CRACKED. REVISION SURGERY HAS NOT BEEN PLANNED.

  Patient problems: Pain

  MAUDE report 7390577 ↗
• InjuryJan 18, 2018Improper or Incorrect Procedure or Method; Mechanical Jam; Positioning Problem; Mechanical Jam

  IT WAS REPORTED THAT; PATIENT WAS PUT IN PRONE POSITION. THIS WAS A REGULAR OPERATION STERILIZATION SPREAD TOWELS, FULL CLEAR SURGICAL FIELD EXPOSURE, CONVENTIONAL CONE, OPEN DEVICE AGENT TAKE NAIL, NEEDLE, THE ESTABLISHMENT OF FLUOROSCOPY LOCATION IS GOOD, CHOOSE SCREW IMPLANT, POOR POSITION AFTER PERSPECTIVE, REMOVE THE SCREW, THE BOOK FOUND THE SCREW ANGLE IS FIXED AND CANNOT BE RESTORED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7203677 ↗
• InjuryOct 3, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; LUMBAR REVISION OF L4-S1. S1 SCREWS WERE BROKEN. PATIENT'S LAST SURGERY WAS DONE IN (B)(6) 2015. WE HAD TO REPLACE THE S1 SCREWS. THE 6.5X40MM WERE BROKEN ON THE SCREW SHAFT. WE HAD TO DRILL THEM OUT AND REPLACE WITH 7.5X 50MM SCREWS.

  Patient problems: Injury; No Code Available

  MAUDE report 5995382 ↗
• MalfunctionOct 3, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; LUMBAR REVISION OF L4-S1. S1 SCREWS WERE BROKEN. PATIENT'S LAST SURGERY WAS DONE IN (B)(6) 2015. WE HAD TO REPLACE THE S1 SCREWS. THE 6.5X40MM WERE BROKEN ON THE SCREW SHAFT. WE HAD TO DRILL THEM OUT AND REPLACE WITH 7.5X 50MM SCREWS.

  Patient problems: Injury; No Code Available

  MAUDE report 5995354 ↗