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XIA 4 5 48135103Recalls & reported problems

Stryker Corporation · EXTENDED CONNECTOR SMALL · Class 2 · Implant

Adverse event reports
8
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540449580), received between Feb 24, 2016 and Feb 3, 2022 — classified as 7 injuries, 1 malfunction.

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

Device problems

  • Fracture6
  • Break5
  • Material Integrity Problem2
  • Crack1

Patient problems

  • Injury4
  • No Code Available4
  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient2
  • No Information1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 3, 2022Fracture; Fracture

    A PATIENT WAS REVISED AFTER TWO XIA 4.5 TITANIUM EXTENDED CONNECTORS FRACTURED. THIS REPORT CAPTURES THE FIRST OF TWO CONNECTORS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13446895 ↗
  • InjuryFeb 3, 2022Fracture; Fracture

    A PATIENT WAS REVISED AFTER TWO XIA 4.5 TITANIUM EXTENDED CONNECTORS FRACTURED. THIS REPORT CAPTURES THE SECOND OF TWO CONNECTORS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13446892 ↗
  • InjurySep 12, 2018Fracture

    IT WAS REPORTED THAT THE EXTENDED CONNECTOR WAS FRACTURED IN THE PATIENT'S BODY. REVISION SURGERY WAS COMPLETED TO REMOVE THE FRACTURED DEVICE, AND A REPLACEMENT WAS USED.

    Patient problems: Injury; No Code Available

    MAUDE report 7870642 ↗
  • MalfunctionJun 12, 2017Break; Fracture; Fracture

    IT WAS REPORTED THAT; A PRIMARY SURGERY FOR INFANT SCOLIOSIS WAS PERFORMED ON (B)(6) 2014. DURING SMALL GROWING ROD EXTENSION SURGERY, A BREAKAGE OF THE EXTENSION CONNECTOR WAS FOUND AND IT WAS EXCHANGED WITH OTHER NEW ONE.

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

    MAUDE report 6635480 ↗
  • InjuryAug 3, 2016Break

    IT WAS REPORTED THAT; REMOVAL OF BROKEN ROD EXTENDER.

    Patient problems: No Code Available

    MAUDE report 5842789 ↗
  • InjuryJul 26, 2016Break; Fracture; Fracture

    IT WAS REPORTED THAT; A PRIMARY SURGERY FOR INFANT SCOLIOSIS WAS PERFORMED ON (B)(6) 2015. ON (B)(6) 2016, THIRD EXTENSION OF THE RODS WAS PERFORMED. THEN, A BREAKAGE OF THE EXTENSION CONNECTOR WAS FOUND AND THE REVISION OF EXCHANGE OF THE CONNECTORS WAS PERFORMED ON (B)(6) 2016.

    Patient problems: Injury; No Code Available

    MAUDE report 5821833 ↗
  • InjuryMay 10, 2016Break; Crack; Material Integrity Problem; Crack; Material Integrity Problem

    THE DEVICE IS REPORTED TO BE BROKEN AFTER SURGERY.

    Patient problems: Injury; No Information

    MAUDE report 5645538 ↗
  • InjuryFeb 24, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

    IT WAS REPORTED THAT THE TWO EXTENDED CONNECTORS WERE FOUND BROKEN DURING REVISION OPERATION AND REPLACED NEW. THE HOSPITAL CAN ONLY RETURN ONE OF THE PRODUCTS.

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

    MAUDE report 5458133 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.