XIA 4 5 48133480Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540449412), received between Nov 18, 2016 and Jul 3, 2020 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionJul 3, 2020Fracture; Fracture

  DURING AN OPERATION TO EXTEND THE ORIGINAL CONSTRUCT, IT WAS NOTICED THAT A XIA TITANIUM 4.5 ROD ON THE RIGHT SIDE WAS BROKEN, AS WELL TWO XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTORS AT THE T11-L1 AND T3/4 LEVELS. THIS REPORT REPRESENTS THE ROD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228233 ↗
• MalfunctionAug 29, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING A FOLLOW UP, THE ROD WAS BROKEN. THE BROKEN ROD WAS CONNECTED BY ROD CONNECTOR AS TREATMENT.

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

  MAUDE report 6827637 ↗
• InjuryJan 20, 2017Fracture

  IT WAS REPORTED THAT THE PATIENT CLAIMED BACK PAIN .AFTER TAKING SOME GRAPHICS HAS BEEN FOUND OUT THAT THE ROD AND THE CONNECTOR HAS BEEN BROKEN. FIRST SURGERY WAS PERFORMED ON (B)(6) 2014. DATE OF EVENT: ABOUT 2 MONTHS BEFORE THE REVISION DATE. DATE OF EXPLANT - (B)(6) 2016. THE SURGEONS' OPINION IS THAT A FATIGUE FRACTURE OCCURRED FOR THE ROD BUT FOR THE CONNECTOR HE HAS NO IDEA ABOUT THE REASON OF FRACTURE.

  Patient problems: Injury; Pain

  MAUDE report 6267816 ↗
• InjuryNov 18, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS A MUST FOR A PATIENT THAT HAS FALLEN IN THE BATHROOM. PATIENT CLAIMED SEVERE PAIN DUE TO THE BROKEN RODS, AND THE REVISION SURGERY WAS RECOMMENDED. THE SURGEON EXPLANTS BROKEN RODS AND REPLACED THEM WITH NEW ONE ALSO EXTENDED CONNECTORS ARE REPLACED AS WELL.

  Patient problems: Fall; Injury; Pain

  MAUDE report 6113410 ↗