XIA 3 48233540Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327001037), received between May 22, 2017 and May 25, 2021 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 11 most recent of 11 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 EIGHTH OF THE EIGHT SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881484 ↗
• MalfunctionMay 25, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TULIPS OF 9 XIA UNIPLANAR SCREWS DISENGAGED FROM THEIR RESPECTIVE SCREW SHAFTS INTRA-OPERATIVELY. 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 EIGHTH OF THE NINE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881329 ↗
• MalfunctionApr 23, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TULIPS OF 2 XIA UNIPLANAR SCREWS DISENGAGED FROM THEIR RESPECTIVE SCREW SHAFTS INTRA-OPERATIVELY. 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 TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721014 ↗
• MalfunctionApr 23, 2021Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event

  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 RETURNED SCREW WHICH SHOWS NO SIGNS OF TULIP DISENGAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721013 ↗
• InjuryMar 1, 2021Material Separation; Material Separation

  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 SCREWS WERE EXPLANTED. THIS REPORT WILL CAPTURE THE SECOND OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396623 ↗
• InjuryMar 1, 2021Material Separation; Material Separation

  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 SCREWS WERE EXPLANTED. THIS REPORT WILL CAPTURE THE FIRST OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396618 ↗
• 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 11396601 ↗
• 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 11396597 ↗
• InjuryMay 3, 2018Migration; Break; Migration

  IT WAS REPORTED THAT A PATIENT HAD A PROCEDURE ON (B)(6) 2016 FOR ADOLESCENT SCOLIOSIS CORRECTION. SURGERY WENT WELL, CORRECTION OBTAINED WITH NO COMPLICATION. SCREWS PLACED T3-L3. PATIENT WAS BROUGHT BACK FOR SURGERY (B)(6) 2018 DUE TO L3 LEFT SIDED SCREW BACKED OUT AND POTENTIAL CAUSE OF PAIN. SURGEON DECIDED TO REMOVE ALL INSTRUMENTATION AS THE SPINE HAS FUSED AND INSTRUMENTATION NO LONGER NEEDED. ON REMOVING THE SCREWS, ONE OF THE SCREWS WAS FOUND BROKEN. THIS CAUSED NO ISSUE TO THE PATIENT AND WASN'T THE REASON FOR THE REVISION SURGERY. THE PATIENT HAD A TOTAL OF 21 SCREWS IN ORIGINALLY. ONE SCREW HAD BACKED OUT AND ONE SCREW WAS BROKEN.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 7483031 ↗
• MalfunctionMay 23, 2017Disassembly; Device Slipped; Disassembly

  IT WAS REPORTED THAT; DURING REVISION SURGERY- WAS NOTED BY SURGEON THAT THERE WAS ROD SLIPPAGE. UPDATE 5/23/2017. THE REASON FOR THE REVISION SURGERY WAS DUE TO PSEUDOARTHRITIS, NON FUSION. WHEN THE SURGEON WENT IN TO TREAT THE PSEUDOARTHRITIS, THE ROD SLIPPAGE WAS NOTICED. PRIOR TO THE REVISION SURGERY, THERE WAS NO INDICATION/ISSUE NOTICED INVOLVING ANY OF THE PREVIOUS IMPLANTED PRODUCTS.

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

  MAUDE report 6586528 ↗
• MalfunctionMay 22, 2017Detachment Of Device Component; Loose or Intermittent Connection; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON WAS UNDERTAKING A SPINAL PROCEDURE AND AFTER EVERYTHING HAD BEEN LOCKED DOWN THE SURGEON FELT THAT THE CONSTRUCT WAS LOOSE. HE FELT AROUND TO UNDERSTAND WHAT WAS HAPPENING AND AS HE DID SO THE TULIP HEAD CAME OFF THE SCREW IN THE SURGEON'S HAND. THE SURGEON WAS ABLE TO REMOVE THE SHAFT OF THE SCREW AND INSERT A NEW ONE. THE CASE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WAS A COUPLE OF MINUTES DELAY WHILE THE NEW SCREW WAS INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6582643 ↗