XIA 3 48233600Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540560735), received between May 25, 2016 and May 24, 2024 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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.

• InjuryMay 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS AN XIA-3 TITANIUM ROD FRACTURE.

  Patient problems: Insufficient Information

  MAUDE report 19392758 ↗
• InjuryMar 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA 3 TITANIUM RODS FRACTURED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED . AND THE RODS WERE EXCHANGED. THIS REPORT REPRESENTS THE SECOND OF THE TWO RODS.

  Patient problems: Pain

  MAUDE report 9901285 ↗
• InjuryMar 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA 3 TITANIUM RODS FRACTURED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED AND THE RODS WERE EXCHANGED. THIS REPORT REPRESENTS THE FIRST OF THE TWO RODS.

  Patient problems: Pain

  MAUDE report 9900712 ↗
• InjuryJun 27, 2019Fracture; Loose or Intermittent Connection

  PHYSICIAN REPORTED THAT TWO RODS WERE FRACTURED POST-OPERATIVELY (CONFIRMED VIA X-RAY). DURING REVISION SURGERY, THE PHYSICIAN NOTED THREE ROD-TO-ROD CONNECTORS WERE LOOSE. THE FRACTURED RODS AND LOOSE CONNECTORS WERE REPLACED. THIS RECORD REPRESENTS TWO OF THE TWO LOOSE ROD-TO-ROD CONNECTORS.

  Patient problems: Injury

  MAUDE report 8739918 ↗
• InjuryJun 21, 2019Fracture; Device Slipped

  PHYSICIAN REPORTED THAT TWO RODS WERE FRACTURED POST-OPERATIVELY (CONFIRMED VIA X-RAY). DURING REVISION SURGERY, THE PHYSICIAN NOTED THREE ROD-TO-ROD CONNECTORS WERE LOOSE. THE FRACTURED RODS AND LOOSE CONNECTORS WERE REPLACED. THIS RECORD REPRESENTS ONE OF THE TWO LOOSE ROD-TO-ROD CONNECTORS.

  Patient problems: Injury

  MAUDE report 8725064 ↗
• InjuryMay 31, 2018Device Dislodged or Dislocated; Migration; Migration

  IT WAS REPORTED THAT A POSTERIOR ORTHODONTIC SURGERY WAS PERFORMED WITH SCOLIOSIS ON (B)(6) 2018. ON (B)(6) 2018, IT WAS REPORTED THAT THE ROD ON THE COCCYX SIDE IS DISLODGED FROM THE SCREW HEAD. LOOSENING AND DETACHMENT OF THE BLOCKER COULD NOT BE CONFIRMED. RE-OPERATION WILL BE PERFORMED IN THE FUTURE.

  Patient problems: Injury; No Code Available

  MAUDE report 7558673 ↗
• MalfunctionApr 24, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; WHEN THE ROD WAS BENT WITH INSITU BENDER, THE ROD WAS BROKEN. AFTER THAT, THE ROD WAS CHANGED THE NEW ONE AND THE OPERATION WAS SUCCEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6517299 ↗
• InjuryNov 21, 2016Mechanical Problem; Break; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT: ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY. AFTER SURGERY, WHEN THE SURGEON CHECKED X-RAY, THE ROD WAS BROKEN(L5-S). THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016. DURING REVISION SURGERY, THE SURGEON TIGHTENED THE BLOCKER USING THE TORQUE WRENCH. WHEN THE SURGEON PULLED OUT THE TORQUE WRENCH, THE SCREW HEAD SEPARATED(L5 RIGHT AND IL LEFT). THEREFORE THE SURGEON CHANGED THE SCREW TO ANOTHER SAME SIZE SCREW.

  Patient problems: Injury; No Information

  MAUDE report 6118597 ↗
• MalfunctionNov 21, 2016Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT: ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY. AFTER SURGERY, WHEN THE SURGEON CHECKED X-RAY, THE ROD WAS BROKEN(L5-S). THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016. DURING REVISION SURGERY, THE SURGEON TIGHTENED THE BLOCKER USING THE TORQUE WRENCH. WHEN THE SURGEON PULLED OUT THE TORQUE WRENCH, THE SCREW HEAD SEPARATED(L5 RIGHT AND IL LEFT). THEREFORE THE SURGEON CHANGED THE SCREW TO ANOTHER SAME SIZE SCREW.

  Patient problems: Injury; No Code Available

  MAUDE report 6118595 ↗
• InjuryMay 25, 2016Break

  IT WAS REPORTED THAT; ON (B)(6) 2014,(TH10-S2AI) SURGERY WAS PERFORMED. AFTER THAT, THE BREAKAGE OF THE BOTH SIDE ROD AT UNDER L4 WAS FOUND. THE MAC WAS ALSO BROKEN AT L5/S1 AND THE SCREW WAS ALSO BROKEN AT LEFT SAI. SO THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2016, AT L4/5 WAS DONE. THE SPINAL DEFORMITY OF THE PATIENT WAS TERRIBLE.

  Patient problems: No Code Available

  MAUDE report 5680353 ↗