XIA 3 482316540Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540562234), received between Jul 9, 2016 and Jul 24, 2025 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY SIX MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED XIA 3 POLYAXIAL SCREWS. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22594597 ↗
• InjuryJul 24, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY SIX MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED XIA 3 POLYAXIAL SCREWS. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22593449 ↗
• InjuryJun 24, 2019Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED ¿A PATIENT IMPLANTED IN (B)(6) 2017 WITH ¿SCREWS AND ROD¿ HAS DEVELOPED A GENERALIZED PRURITUS THAT DOES NOT DISAPPEAR SINCE THE IMPLANTATION.¿ THE PHYSICIAN SUGGESTS THE PATIENT MAY HAVE AN ALLERGY TO A COMPONENT OF THE DEVICE. DETAILS OF SPECIFIC MEDICAL INTERVENTION HAVE NOT BEEN PROVIDED AND THE PATIENT HAS CONSULTED WITH A DERMATOLOGIST. THIS RECORD REPRESENTS 3 OF 3 SCREW.

  Patient problems: Itching Sensation

  MAUDE report 8729388 ↗
• InjuryJun 24, 2019Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  PHYSICIAN REPORTED ¿A PATIENT IMPLANTED IN (B)(6) 2017 WITH ¿SCREWS AND ROD¿ HAS DEVELOPED A GENERALIZED PRURITUS THAT DOES NOT DISAPPEAR SINCE THE IMPLANTATION.¿ THE PHYSICIAN SUGGESTS THE PATIENT MAY HAVE AN ALLERGY TO A COMPONENT OF THE DEVICE. DETAILS OF SPECIFIC MEDICAL INTERVENTION HAVE NOT BEEN PROVIDED AND THE PATIENT HAS CONSULTED WITH A DERMATOLOGIST. THIS RECORD REPRESENTS 2 OF 3 SCREW.

  Patient problems: Itching Sensation

  MAUDE report 8729387 ↗
• InjuryJun 24, 2019Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  PHYSICIAN REPORTED ¿A PATIENT IMPLANTED IN (B)(6) 2017 WITH ¿SCREWS AND ROD¿ HAS DEVELOPED A GENERALIZED PRURITUS THAT DOES NOT DISAPPEAR SINCE THE IMPLANTATION.¿ THE PHYSICIAN SUGGESTS THE PATIENT MAY HAVE AN ALLERGY TO A COMPONENT OF THE DEVICE. DETAILS OF SPECIFIC MEDICAL INTERVENTION HAVE NOT BEEN PROVIDED AND THE PATIENT HAS CONSULTED WITH A DERMATOLOGIST. THIS RECORD REPRESENTS 1 OF 1 SCREW.

  Patient problems: Itching Sensation

  MAUDE report 8729054 ↗
• InjuryJun 24, 2019Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  PHYSICIAN REPORTED ¿A PATIENT IMPLANTED IN (B)(6) 2017 WITH ¿SCREWS AND ROD¿ HAS DEVELOPED A GENERALIZED PRURITUS THAT DOES NOT DISAPPEAR SINCE THE IMPLANTATION.¿ THE PHYSICIAN SUGGESTS THE PATIENT MAY HAVE AN ALLERGY TO A COMPONENT OF THE DEVICE. DETAILS OF SPECIFIC MEDICAL INTERVENTION HAVE NOT BEEN PROVIDED AND THE PATIENT HAS CONSULTED WITH A DERMATOLOGIST. THIS RECORD REPRESENTS 3 OF 4 SCREWS.

  Patient problems: Itching Sensation

  MAUDE report 8728990 ↗
• InjuryJun 24, 2019Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  PHYSICIAN REPORTED ¿A PATIENT IMPLANTED IN (B)(6) 2017 WITH ¿SCREWS AND ROD¿ HAS DEVELOPED A GENERALIZED PRURITUS THAT DOES NOT DISAPPEAR SINCE THE IMPLANTATION.¿ THE PHYSICIAN SUGGESTS THE PATIENT MAY HAVE AN ALLERGY TO A COMPONENT OF THE DEVICE. DETAILS OF SPECIFIC MEDICAL INTERVENTION HAVE NOT BEEN PROVIDED AND THE PATIENT HAS CONSULTED WITH A DERMATOLOGIST. THIS RECORD REPRESENTS 4 OF 4 SCREWS.

  Patient problems: Itching Sensation

  MAUDE report 8728980 ↗
• InjuryJun 24, 2019Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  PHYSICIAN REPORTED ¿A PATIENT IMPLANTED IN (B)(6) 2017 WITH ¿SCREWS AND ROD¿ HAS DEVELOPED A GENERALIZED PRURITUS THAT DOES NOT DISAPPEAR SINCE THE IMPLANTATION.¿ THE PHYSICIAN SUGGESTS THE PATIENT MAY HAVE AN ALLERGY TO A COMPONENT OF THE DEVICE. DETAILS OF SPECIFIC MEDICAL INTERVENTION HAVE NOT BEEN PROVIDED AND THE PATIENT HAS CONSULTED WITH A DERMATOLOGIST. THIS RECORD REPRESENTS 2 OF 4 SCREW.

  Patient problems: Itching Sensation

  MAUDE report 8728975 ↗
• InjuryJun 24, 2019Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  PHYSICIAN REPORTED A PATIENT IMPLANTED IN (B)(6) 2017 WITH ¿SCREWS AND ROD¿ HAS DEVELOPED A GENERALIZED PRURITUS THAT DOES NOT DISAPPEAR SINCE THE IMPLANTATION. THE PHYSICIAN SUGGESTS THE PATIENT MAY HAVE AN ALLERGY TO A COMPONENT OF THE DEVICE. DETAILS OF SPECIFIC MEDICAL INTERVENTION HAVE NOT BEEN PROVIDED AND THE PATIENT HAS CONSULTED WITH A DERMATOLOGIST. THIS RECORD REPRESENTS 1 OF 4 SCREWS.

  Patient problems: Itching Sensation

  MAUDE report 8728972 ↗
• MalfunctionMar 19, 2019Break; Fracture; Appropriate Device Problem Term/Code Not Available; Fracture

  IT WAS REPORTED THAT THE DURING REVISION SURGERY (TO TREAT ADJACENT INTERVERTEBRAL DISORDER), WHILE REMOVING THE SCREW, THE SCREW WAS FOUND TO BE BROKEN. THE FRACTURED SCREW WAS REMOVED, AND A NEW SCREW IS INSERTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 8431862 ↗
• MalfunctionJun 6, 2018Break; Fracture; Fracture

  IT IS REPORTED THAT DURING A REVISION SURGERY A SCREW BROKE. THE BROKEN SCREW WAS LEFT INSIDE THE PATIENT. REVISION SURGERY WAS PERFORMED DUE TO PATIENT FACTOR: ADJACENT INTERVERTEBRAL DISORDERS, EXTENSION WAS PERFORMED ON L2 TO S1. NO ADVERSE CONSEQUENCES HAS BEEN REPORTED DUE TO SCREW BREAKAGE.

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

  MAUDE report 7572788 ↗
• InjuryJun 5, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; THE DOCTOR REPORTED TO SALES REP THAT TWO OUT OF FOUR IMPLANTED SCREWS HAD BEEN FOUND BROKEN AFTER 2 YEARS FROM THE INITIAL SURGERY - (B)(6) 2015. A REVISION SURGERY IS SCHEDULED WITHIN 2 WEEKS.

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

  MAUDE report 6613085 ↗
• InjuryJul 9, 2016Break

  IT WAS REPORTED THAT; REVISION CASE OF A BROKEN SCREW. PATIENT WAS (B)(6). HAD 2 SCREWS IN PATIENT ON THE LEFTSIDE L4-L5. THE SCREW IN L4 BROKE. PATIENT WAS NOT HARMED BUT HAD TO HAVE SURGERY TO TAKE BROKEN PIECE OUT.THE PIECE WILL BE SENT BACK TO YOU. THE DOCTOR LEFT THE SECOND HALF OF THE SCREW IN THE PATIENTS HE SAID IT WOULD BE MORE HARMFUL TO TAKE IT OUT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5780593 ↗