XIA 4 5 48135104Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540449597), received between Jun 27, 2016 and Feb 3, 2022 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST-OPERATIVELY A XIA 4.5 TITANIUM CONNECTOR BROKE. REVISION SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446816 ↗
• InjuryJan 3, 2020Fracture; Fracture

  IT WAS REPORTED THAT A XIA TITANIUM CONNECTOR FRACTURED POST-OPERATIVELY. THE PATIENT HAS BEEN REVISED.

  Patient problems: Injury

  MAUDE report 9548076 ↗
• InjuryJan 3, 2020Fracture; Fracture

  IT WAS REPORTED THAT A XIA TITANIUM CONNECTOR FRACTURED POST-OPERATIVELY. THE PATIENT HAS BEEN REVISED.

  Patient problems: Injury

  MAUDE report 9548027 ↗
• InjuryOct 28, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE EXTENDED CONNECTOR HAS BROKEN INSIDE THE PATIENT. THE PATIENT WAS COMPLAINING OF THE PAIN AND THE EVENT WAS CONFORMED VIA X-RAY EXAMINATION. THE PATIENT UNDERWENT REVISION SURGERY.

  Patient problems: Injury; Pain

  MAUDE report 8011511 ↗
• MalfunctionJun 26, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; THE SURGEON INFORMED US THAT DURING A PLANNED ELONGATION CHECK IT WAS SEEN THAT THE CODE WAS BROKEN. THE DEVICE WAS REPLACED DURING THE SURGERY. THE PATIENT HAD NO CONSEQUENCES DUE TO THE BREAKAGE AND THE ELONGATION ACTION HAD TO BE ROUTINELY PERFORMED. THE DATE OF THE EVENT IS NOT REPORTED.

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

  MAUDE report 6667912 ↗
• MalfunctionJan 20, 2017Break; Fracture; Fracture

  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 6267815 ↗
• InjuryNov 2, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT AFTER 6 MONTHS FROM THE DATE OF THE LAST ROD LENGTHENING SURGERY THE GROWING CONNECTOR HAS BEEN BROKEN. SURGEON DID A REVISION SURGERY AND REPLACED THE ITEM WITH A NON-STRYKER PRODUCT. SURGEON'S OPINION - FRACTURE IS CAUSED BY FATIGUE.

  Patient problems: Injury; No Information

  MAUDE report 6074095 ↗
• InjuryAug 3, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT; THE PATIENT REPORTED PAIN. DURING X-RAYS EXAMINATION THE SURGEON NOTICED THAT THE CONNECTOR IS BROKEN AND HE DECIDED TO PERFORM REVISION SURGERY TO EXCHANGE BROKEN ELEMENTS OF THE SYSTEM.

  Patient problems: Injury; Pain

  MAUDE report 5842770 ↗
• InjuryJun 27, 2016Break

  IT WAS REPORTED THAT; BROKEN CONNECTOR REMOVED FROM PATIENT.

  Patient problems: No Information

  MAUDE report 5753060 ↗