XIA 3 48233535Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327001020), received between Mar 1, 2021 and May 25, 2021 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF 2 XIA UNIPLANAR SCREWS DISENGAGED FROM THEIR RESPECTIVE SCREW SHAFTS INTRA-OPERATIVELY. HOWEVER, AFTER ADDITIONAL INFORMATION RECEIVED AND INVESTIGATION COMPLETION, 8 SCREW TULIPS DISENGAGED. SUBSEQUENTLY, THERE WAS A 60 MINUTE DELAY TO SURGERY AS THE SURGEON REMOVED THE SCREWS AND RODS ON BOTH SIDES TO REDO THE CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE FOURTH OF THE EIGHT SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881467 ↗
• MalfunctionMay 25, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF 2 XIA UNIPLANAR SCREWS DISENGAGED FROM THEIR RESPECTIVE SCREW SHAFTS INTRA-OPERATIVELY. HOWEVER, AFTER ADDITIONAL INFORMATION RECEIVED AND INVESTIGATION COMPLETION, 8 SCREW TULIPS DISENGAGED. SUBSEQUENTLY, THERE WAS A 60 MINUTE DELAY TO SURGERY AS THE SURGEON REMOVED THE SCREWS AND RODS ON BOTH SIDES TO REDO THE CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE THIRD OF THE EIGHT SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881421 ↗
• MalfunctionMay 25, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF 2 XIA UNIPLANAR SCREWS DISENGAGED FROM THEIR RESPECTIVE SCREW SHAFTS INTRA-OPERATIVELY. HOWEVER, AFTER ADDITIONAL INFORMATION RECEIVED AND INVESTIGATION COMPLETION, 8 SCREW TULIPS DISENGAGED. SUBSEQUENTLY, THERE WAS A 60 MINUTE DELAY TO SURGERY AS THE SURGEON REMOVED THE SCREWS AND RODS ON BOTH SIDES TO REDO THE CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE SECOND OF THE EIGHT SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881405 ↗
• MalfunctionMay 25, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF 2 XIA UNIPLANAR SCREWS DISENGAGED FROM THEIR RESPECTIVE SCREW SHAFTS INTRA-OPERATIVELY. HOWEVER, AFTER ADDITIONAL INFORMATION RECEIVED AND INVESTIGATION COMPLETION, 8 SCREW TULIPS DISENGAGED. SUBSEQUENTLY, THERE WAS A 60 MINUTE DELAY TO SURGERY AS THE SURGEON REMOVED THE SCREWS AND RODS ON BOTH SIDES TO REDO THE CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE FIFTH OF THE EIGHT SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881338 ↗
• MalfunctionMay 25, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF 2 XIA UNIPLANAR SCREWS DISENGAGED FROM THEIR RESPECTIVE SCREW SHAFTS INTRA-OPERATIVELY. HOWEVER, AFTER ADDITIONAL INFORMATION RECEIVED AND INVESTIGATION COMPLETION, 8 SCREW TULIPS DISENGAGED. SUBSEQUENTLY, THERE WAS A 60 MINUTE DELAY TO SURGERY AS THE SURGEON REMOVED THE SCREWS AND RODS ON BOTH SIDES TO REDO THE CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE FIRST OF THE EIGHT SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881245 ↗
• InjuryMar 1, 2021Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF NINE XIA DEFORMITY UNIPLANAR SCREWS "RELEASED" POST-OPERATIVELY. HOWEVER, UPON ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THIS ONLY HAPPENED TO 2 SCREW TULIPS. REVISION SURGERY WAS PERFORMED WHERE THE TWO SCREWS WERE EXPLANTED. THERE WAS NO ALLEGED ISSUE WITH THIS SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396613 ↗
• InjuryMar 1, 2021Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF NINE XIA DEFORMITY UNIPLANAR SCREWS "RELEASED" POST-OPERATIVELY. HOWEVER, UPON ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THIS ONLY HAPPENED TO 2 SCREW TULIPS. REVISION SURGERY WAS PERFORMED WHERE THE TWO SCREWS WERE EXPLANTED. THERE WAS NO ALLEGED ISSUE WITH THIS SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396598 ↗
• InjuryMar 1, 2021Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF NINE XIA DEFORMITY UNIPLANAR SCREWS "RELEASED" POST-OPERATIVELY. HOWEVER, UPON ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THIS ONLY HAPPENED TO 2 SCREW TULIPS. REVISION SURGERY WAS PERFORMED WHERE THE TWO SCREWS WERE EXPLANTED. THERE WAS NO ALLEGED ISSUE WITH THIS SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396596 ↗
• InjuryMar 1, 2021Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF NINE XIA DEFORMITY UNIPLANAR SCREWS "RELEASED" POST-OPERATIVELY. HOWEVER, UPON ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THIS ONLY HAPPENED TO 2 SCREW TULIPS. REVISION SURGERY WAS PERFORMED WHERE THE TWO SCREWS WERE EXPLANTED. THERE WAS NO ALLEGED ISSUE WITH THIS SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396594 ↗
• InjuryMar 1, 2021Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE TULIPS OF NINE XIA DEFORMITY UNIPLANAR SCREWS "RELEASED" POST-OPERATIVELY. HOWEVER, UPON ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THIS ONLY HAPPENED TO 2 SCREW TULIPS. REVISION SURGERY WAS PERFORMED WHERE THE TWO SCREWS WERE EXPLANTED. THERE WAS NO ALLEGED ISSUE WITH THIS SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396593 ↗