XIA 3 482318550Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540598608), received between May 15, 2017 and Apr 14, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 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.

• MalfunctionApr 14, 2026Device Dislodged or Dislocated

  A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF A XIA 3 POLYAXIAL SCREW DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877426 ↗
• MalfunctionAug 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING ROD INSERTION THE TULIP OF THE SCREW SPLAYED WHEN A BLOCKER WAS INSERTED INTO THE SCREW TULIP. IT WAS FURTHER REPORTED THAT THE BLOCKER WAS NOT CROSS THREADED. THE SCREW AND BLOCKER WERE LEFT IMPLANTED. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.  THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276025 ↗
• MalfunctionOct 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TULIP OF A XIA 3 TITANIUM POLYAXIAL SCREW AT L4 DISENGAGED LESS THAN A MONTH POST-OPERATIVELY. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10742591 ↗
• InjuryAug 28, 2019Appropriate Device Problem Term/Code Not Available; Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY TO REPLACE A XIA 3 TITANIUM POLYAXIAL SCREW WITH A DISENGAGED TULIP HEAD.

  Patient problems: Injury

  MAUDE report 8942147 ↗
• MalfunctionNov 21, 2017Loose or Intermittent Connection; Mechanical Problem; Device Dislodged or Dislocated; Naturally Worn; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; L5/S1 BY PLIF WAS PERFORMED. WHEN APPLYING COMPRESSION ON THE LEFT SIDE TEMPORARILY FIXED WITH A ROD, THE HEAD OF L5 IS COMPRESSING, THE POSITION OF THE HEAD MOVES CONSIDERABLY AND THEN WHEN TRYING TO FASTEN THE FINAL TIGHTENING WITH A TORQUE WRENCH THE LEFT SIDE OF L5 IDLES AND THE HEAD MOVES. THEREFORE, ONCE THE BLOCKER AND ROD ARE REMOVED, THE HEAD DETACHES. FOR THAT REASON, THE SCREW WAS REPLACED WITH 8.5 X 50 MM OF THE SAME SIZE, COMPRESSION WAS PERFORMED AND FINAL TIGHTENING. WHEN THE DAMAGED SCREW WAS CONFIRMED, THE WASHER BUILT IN THE HEAD WORN OUT AND WAS PARTIALLY DAMAGED. IN ADDITION, PART OF THE SIX POINTER WAS ALSO DAMAGED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7049716 ↗
• MalfunctionMay 15, 2017Detachment Of Device Component; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT; DURING L5-S TLIF SURGERY, THE SCREW HEAD DETACHED FROM THE SCREW SHAFT WHILE THE FINAL TIGHTENING OF S1 RIGHT SCREW. THEN THE SURGEON REPLACE THE SCREW AND FINISHED THE SURGERY WITHOUT PROBLEM.

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

  MAUDE report 6567328 ↗