XIA 3 482317550Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540562364), received between Feb 26, 2016 and Dec 17, 2021 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT THE TULIP OF A XIA 3 POLYAXIAL SCREW DISENGAGED FROM THE SCREW SHAFT APPROXIMATELY 5 YEARS POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026848 ↗
• InjuryDec 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TULIP DISENGAGED FROM THE XIA 3 POLYAXIAL SCREW AT L5, APPROXIMATELY A FEW WEEKS POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12940364 ↗
• MalfunctionMay 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING ROUTINE FOLLOW UP, IT WAS FOUND THAT THE PATIENT EXPERIENCED ROD FRACTURE, CONNECTOR FRACTURE, AND SCREW TULIP DISENGAGEMENT POST-OPERATIVELY. THIS RECORD CAPTURES THE REPORTED TULIP DISENGAGEMENT OF A XIA POLYAXIAL SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886422 ↗
• MalfunctionNov 21, 2016Detachment Of Device Component; Mechanical Problem; Break; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT; ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY. AFTER SURGERY, WHEN THE SURGEON CHECKED X-RAY, THE ROD WAS BROKEN(L5-S). THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016. DURING REVISION SURGERY, THE SURGEON TIGHTENED THE BLOCKER USING THE TORQUE WRENCH. WHEN THE SURGEON PULLED OUT THE TORQUE WRENCH, THE SCREW HEAD SEPARATED(L5 RIGHT AND IL LEFT). THEREFORE THE SURGEON CHANGED THE SCREW TO ANOTHER SAME SIZE SCREW.

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

  MAUDE report 6119066 ↗
• MalfunctionJun 1, 2016Use of Device Problem; Device Operates Differently Than Expected; Device Handling Problem; Use of Device Problem; Device Handling Problem

  IT WAS REPORTED THAT; SCREW HAD BAD THREADING INSIDE TULIP OF 7.5MM X 50MM SCREW. UPDATE (B)(6) 2016): THE THREADING WOULD NOT ALLOW THE POLYAXIAL SCREWDRIVER TO THREAD INTO THE TULIP. ANOTHER SCREW WAS TRIED, AND WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5691236 ↗
• MalfunctionFeb 26, 2016Material Integrity Problem; Break; Detachment Of Device Component; Material Integrity Problem

  PER REPORTED EVENT; THE POLYAXIAL TULIP HEAD BROKE OFF OF THE SCREW WHILE INSERTING THE BLOCKER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5464084 ↗