XIA 3 482318580Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540598653), received between Mar 11, 2016 and Sep 15, 2021 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TULIP CAME OFF OF 2 - XIA 3 TITANIUM POLYAXIAL ILIAC SCREWS POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED WHERE THE DEVICES WERE EXPLANTED. THIS REPORT CAPTURES THE FIRST OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477580 ↗
• InjurySep 15, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TULIP CAME OFF OF 2 - XIA 3 TITANIUM POLYAXIAL ILIAC SCREWS POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED WERE THE DEVICES WERE EXPLANTED. THIS REPORT CAPTURES THE SECOND OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477434 ↗
• MalfunctionDec 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT TWO XIA 3 TITANIUM POLYAXIAL SCREWS TULIP THREADING DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 45 MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS THE FIRST OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11030160 ↗
• MalfunctionDec 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT TWO XIA 3 TITANIUM POLYAXIAL SCREWS TULIP THREADING DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 45 MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS THE SECOND OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11030113 ↗
• InjuryOct 3, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component

  TWO XIA 3 TITANIUM POLYAXIAL SCREW TULIPS DISENGAGED TWO DAYS POST- OPERATIVELY LEADING TO REVISION SURGERY. THIS RECORD CAPTURES THE SECOND SCREW.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 9152330 ↗
• MalfunctionJun 30, 2017Material Integrity Problem; Disconnection; Material Integrity Problem

  IT WAS REPORTED THAT; DURING FINAL TIGHTENING OF THE BLOCKER TO THE ROD/SCREW CONSTRUCT THE SURGEON FELT A LOOSENING OF THE CONSTRUCT. UPON FURTHER EXAMINATION IT WAS NOTED THAT THE TULIP HEAD BECAME DISSOCIATED FROM THE SCREW SHAFT. THE SCREW WAS REMOVED EASILY AND A NEW SCREW WAS PLACED AND FINAL TIGHTENED WITHOUT ANY ISSUES OR DELAYS.

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

  MAUDE report 6681582 ↗
• MalfunctionNov 29, 2016Material Deformation; Device Slipped; Device Operates Differently Than Expected; Material Deformation

  IT WAS REPORTED THAT; DURING SURGERY, THE SURGEON INSERTED THE SCREW TO THE ILIAC. WHEN THE SURGEON TIGHTENED THE BLOCKER OF SCREW, THE BLOCKER WAS POP OUT. THEREFORE THE SURGEON CHANGED THE SCREW TO SAME SIZE ML SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6133348 ↗
• InjuryMar 11, 2016Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ROD AND THE TULIP DISSOCIATED FROM LEFT ILIAC BOLT.

  Patient problems: Injury; No Information

  MAUDE report 5495913 ↗