XIA II 03829650Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154407903), received between Mar 7, 2017 and Apr 5, 2023 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A XIA POLYAXIAL REDUCTION SCREW FRACTURED APPROXIMATELY 1 YEAR AND 1 MONTH POST-OPERATIVELY. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684179 ↗
• MalfunctionJul 21, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021 A PATIENT WAS IMPLANTED WITH A L5-S1 TLIF. WHEN REPOSITIONING THE LEFT L5 SCREW, THE TULIP HEAD OF THE LEFT S1 SCREW CAME OFF. THE LEFT S1 SCREW WAS SUCCESSFULLY REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN AMOUNT OF SURGICAL DELAY. NO ADVERSE CONSEQUENCES RESULTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206730 ↗
• MalfunctionMar 7, 2017Break; Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; DURING SURGERY, TWO REDUCTION SCREW TABS BROKE OFF WHILE TRYING TO REDUCE THE SCREW. THE REDUCTION TABS BROKE OFF SOONER THEN INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6384228 ↗
• MalfunctionMar 7, 2017Break; Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; DURING SURGERY, TWO REDUCTION SCREW TABS BROKE OFF WHILE TRYING TO REDUCE THE SCREW. THE REDUCTION TABS BROKE OFF SOONER THEN INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6384226 ↗