XIA 3 48232601Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04546540608642), received between Mar 8, 2016 and Nov 5, 2025 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Fracture; Fracture

  A CUSTOMER REPORTED THAT A XIA 3 ROD FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED INCREASED BLEEDING AND THAT THIS MAY NOT BE RELATED TO THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23480460 ↗
• InjuryAug 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA 3 VITALIUM RODS FRACTURED POST-OPERATIVELY. THE PATIENT WAS REVISED AND THE RODS WERE EXPLANTED. THIS REPORT CAPTURES THE SECOND ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183333 ↗
• InjuryJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT A XIA 3 VITALIUM ROD FRACTURED POST-OPERATIVELY. THE PATIENT WAS REVISED AND THE ROD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658017 ↗
• InjuryJan 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA 3 RODS BROKE POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED WHERE THE RODS HAVE BEEN REPLACED. THIS REPORT WILL CAPTURE THE FIRST OF TWO RODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156831 ↗
• InjuryJan 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA 3 RODS BROKE POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED WHERE THE RODS HAVE BEEN REPLACED. THIS REPORT WILL CAPTURE THE SECOND OF TWO RODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156823 ↗
• MalfunctionJan 11, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE XIA 3 VITALIUM ROD SNAPPED WHILE BENDING INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11148016 ↗
• MalfunctionOct 19, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE ROD SNAPPED IN HALF WHEN USED WITH A FRENCH BENDER. PER EMAIL CONVERSATION ALL FRAGMENTS WERE REMOVED AND SURGERY COMPLETED SUCCESSFULLY WITH DIFFERENT ROD. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

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

  MAUDE report 7987122 ↗
• MalfunctionAug 22, 2018Break; Fracture; Fracture

  IT WAS REPORTED THE ROD BROKE WHEN THE DOCTOR WAS TRYING TO BEND IT. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS A 10 MINUTE SURGICAL DELAY ASSOCIATED WITH THE EVENT.

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

  MAUDE report 7804323 ↗
• MalfunctionMar 23, 2018Fracture; Break; Fracture

  IT WAS REPORTED THE ROD BROKE UPON FIRST BEND USING FRENCH BENDERS. THIS OCCURRED OUTSIDE OF THE PATIENT'S CAVITY. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7365137 ↗
• InjuryJun 27, 2017Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014, AND 1ST REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. IT WAS REPORTED AS (B)(6). THE ROD BREAKAGE DUE TO THE NONUNION WAS FOUND (RIGHT T9/10, LEFT T10/11), THE 2ND REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. DURING THE SURGERY, THE SET SCREWS OF THE CONNECTOR SNAPPED OFF. THE SURGEON EXCHANGED WITH THE NEW SCREWS.

  Patient problems: Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6671818 ↗
• MalfunctionApr 17, 2017Break; Detachment Of Device Component; Component Falling; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; THE ROD WAS CUT. WHILE BENDING THE VITALLIUM ROD WITH THE FRENCH BENDER, THE PRODUCT BROKE IN HALF ON THE BACK TABLE ABOUT 2 INCHES IN. DURING SURGERY WHILE PUTTING THE ROD IN THE SCREW, THE HEAD FELL OFF OF THE SCREW. THE SCREW WAS ALREADY IN THE PATIENT. ALL BROKEN FRAGMENTS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6498753 ↗
• InjuryMar 22, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; PATIENT FELL AND IT WAS NOTICED THAT THE ROD BROKE. REVISION SURGERY (B)(6) 2017. PATIENT FUSED.

  Patient problems: Fall; Injury

  MAUDE report 6425576 ↗
• MalfunctionApr 27, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT VITALLIUM ROD BROKE DURING PRE-OP PREPARATION (BENDING OF THE ROD).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5610935 ↗
• MalfunctionMar 31, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; A VITALLIUM ROD BROKE WHILE SURGEON WAS USING A FRENCH BENDER DURING A SCOLI CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5537884 ↗
• MalfunctionMar 29, 2016Break

  IT WAS REPORTED THAT DURING A SURGERY, THE ROD BROKE WHEN THE SURGEON WAS BENDING IT. AFTER THAT THE SURGEON USED ANOTHER ROD AND FINISHED THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5531901 ↗
• MalfunctionMar 8, 2016Break

  IT WAS REPORTED THAT WHILE BENDING RODS USING A FRENCH BENDER 2 RODS BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5485513 ↗