XIA I 03805002Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540147998), received between Sep 5, 2017 and Jul 10, 2024 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT TWO XIA ROD TO ROD CLAMPS DID NOT RETAIN THEIR RESPECTIVE RODS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR THE FIRST OF TWO XIA ROD TO ROD CLAMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716280 ↗
• MalfunctionJul 10, 2024Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT TWO XIA ROD TO ROD CLAMPS DID NOT RETAIN THEIR RESPECTIVE RODS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR THE SECOND OF TWO XIA ROD TO ROD CLAMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715991 ↗
• InjuryJun 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2016 FOR L3-L4. ON (B)(6) 2016, EXTENSION WAS PERFORMED FOR TH7. UPON FOLLOW UP, ON (B)(6) 2018, IT WAS CONFIRMED A ROD DISLODGED FROM THE ROD TO ROD CLAMP CONNECTOR. REVISION WAS PERFORMED (B)(6) 2018 DUE TO PATIENT PAIN.

  Patient problems: Injury

  MAUDE report 7623035 ↗
• MalfunctionApr 11, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT WHILE IMPACTING THE CAGE INTO DISC SPACE AT L3/4, THE CAGE BROKE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 7423296 ↗
• InjuryApr 2, 2018Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT A PATIENT PRESENTED INCREASING BACK PAIN AT 1 YEAR OUT MEETING. X-RAYS SHOWED THAT BOTH RODS WERE DISLODGED FROM THE AXIAL CONNECTORS AT THE L1 LEVEL. REVISION SURGERY HAS BEEN SCHEDULED FOR THE PATIENT.

  Patient problems: Injury; Pain

  MAUDE report 7390661 ↗
• InjuryMar 9, 2018Migration or Expulsion of Device; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2016 FOR L3-L4. ON (B)(6) 2016, EXTENSION WAS PERFORMED FOR TH7. UPON FOLLOW UP, ON (B)(6) 2018, IT WAS CONFIRMED A ROD DISLODGED FROM THE ROD TO ROD CLAMP CONNECTOR. THERE WAS NO PLAN FOR REVISION SURGERY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 7328861 ↗
• InjuryOct 9, 2017Migration or Expulsion of Device; Noise, Audible; Migration or Expulsion of Device

  IT WAS REPORTED THAT; PATIENT PRESENTED WITH END TO END AXIAL CONNECTOR ISSUE PATIENT IS COMING BACK FOR A REVISION SURGERY. DETAILS PENDING. UPDATE (B)(6) 2017: PATIENT WAS DOING WELL POST-OP UNTIL HE BENT OVER AND SIMPLY HEARD A "POP" NOISE. THUS RESULTING IN PAIN AND PHYSICIANS VISIT.

  Patient problems: Complaint, Ill-Defined; Injury; Pain

  MAUDE report 6930792 ↗
• InjurySep 5, 2017Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT; PATIENT PRESENTED TO THE SURGEON WITH PAIN FOLLOWING A FALL. THE PREVIOUS CASE WAS PERFORMED ON (B)(6) 2017 FOR PSEUDOARTHORSIS OF L5-S1. THE PATIENT WAS REVISED USING NEW SCREW WITH CONNECTORS. THE ROD PULLED OUT FROM THE RIGHT SIDE AND THERE IS SUSPICION THAT THE ROD PULLED OUT FROM THE LEFT SIDE AS WELL. THE PATIENT BONE QUALITY WAS AVERAGE AND THE PATIENT ACTIVITY WAS MODERATE. PATIENT WILL UNDERGO A REVISION SURGERY ON (B)(6) 2017. THIS IS THE THIRD REVISION SURGERY THE PATIENT WILL HAVE. THE OTHER REVISION SURGERIES WERE NOT RELATED TO ANY INSTRUMENTATION ISSUES.

  Patient problems: Injury; Pain

  MAUDE report 6843609 ↗