XIA 4 5 48133236Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540515094), received between Apr 10, 2017 and Aug 26, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2020Fracture; Fracture

  DURING A PLANNED REVISION TO EXTEND THE GROWING ROD, THE SURGEON FOUND THAT THE ORIGINAL XIA 4.5 POLYAXIAL CROSS CONNECTOR WAS BROKEN POST-OPERATIVELY. FUSION HAD BEEN ACHIEVED AND THE CROSS CONNECTOR WAS REMOVED. THE OPERATION WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10455773 ↗
• MalfunctionMay 19, 2020Difficult to Insert; Mechanical Jam; Difficult to Insert; Mechanical Jam

  IT WAS REPORTED THAT TWO XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR SECURING MECHANISMS JAMMED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT REPRESENTS THE SECOND OF TWO CROSS CONNECTORS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10072861 ↗
• MalfunctionMay 19, 2020Difficult to Insert; Mechanical Jam; Difficult to Insert; Mechanical Jam

  IT WAS REPORTED THAT TWO XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR SECURING MECHANISMS JAMMED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT REPRESENTS THE FIRST OF TWO CROSS CONNECTORS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10072698 ↗
• MalfunctionApr 24, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT; DURING SMALL SURGERY, THE SURGEON USED THE CROSS LINK CONNECTOR. WHEN THE SURGEON LOOSENED THE NUT OF ONE SIDE OF THE CONNECTOR, THE NUT WAS NOT LOOSENED. THEREFORE THE SURGEON CHANGED THE CONNECTOR TO ANOTHER SAME SIZE CONNECTOR.

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

  MAUDE report 6517332 ↗
• MalfunctionApr 10, 2017Crack; Fracture; Material Integrity Problem; Physical Property Issue; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT "WHEN TRYING TO MOVE THE CROSSLINK AFTER PLACING IT ON THE CONSTRUCT, IT APPEARS THAT EITHER THE HEXDRIVER STRIPPED OR THE LOCKING SCREW STRIPPED OUT. AS A RESULT, WE HAD TO REMOVE THE ROD AND MANUALLY SLIDE THE CONNECTOR OFF THE ROD. UPON GRABBING A REPLACEMENT CONNECTOR, IT WAS FOUND THAT THE NEW CONNECTORS LOCKING SCREW WAS CRACKED. THE SURGEONS BELIEVE THAT MAY HAVE BEEN AN ISSUE WITH THE FIRST CONNECTOR."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6477515 ↗