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XIA 3 48235010Recalls & reported problems

Stryker Corporation · ANGLED LOADING-SIDE-LOADING RRC · Class 2 · Implant

All models of XIA 3 (93)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540602404), received between Oct 10, 2016 and May 26, 2021 — classified as 3 injuries, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Fracture4
  • Break1
  • Detachment of Device or Device Component1
  • Difficult to Insert1
  • Loose or Intermittent Connection1
  • Mechanical Problem1
  • Use of Device Problem1

Patient problems

  • Pain3
  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 26, 2021Fracture; Fracture

    DURING ROUTINE FOLLOW UP, IT WAS FOUND THAT THE PATIENT EXPERIENCED ROD FRACTURE, CONNECTOR FRACTURE, AND SCREW TULIP DISENGAGEMENT POST-OPERATIVELY. THIS RECORD CAPTURES THE REPORTED FRACTURE OF A XIA 3 PARALLEL CONNECTOR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11886427 ↗
  • InjuryJun 19, 2020Fracture; Fracture

    IT WAS REPORTED THAT TWO XIA 3 TITANIUM PARALLEL CONNECTORS 'BROKE' POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE CONNECTORS WERE REPLACED. THIS RECORD REPRESENTS THE SECOND OF THE TWO CONNECTORS.

    Patient problems: Pain

    MAUDE report 10176482 ↗
  • InjuryJun 19, 2020Fracture; Fracture

    IT WAS REPORTED THAT TWO XIA 3 TITANIUM PARALLEL CONNECTORS 'BROKE' POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE CONNECTORS WERE REPLACED. THIS RECORD REPRESENTS THE FIRST OF THE TWO CONNECTORS.

    Patient problems: Pain

    MAUDE report 10176435 ↗
  • InjurySep 12, 2019Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem

    A PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED PAIN POST-OPERATIVELY. IMAGING INDICATED THAT A ROD HAD DETACHED FROM THE XIA 3 TITANIUM PARALLEL SIDE-LOADING CONNECTOR. THE PATIENT UNDERWENT REVISION SURGERY.

    Patient problems: Pain

    MAUDE report 9000861 ↗
  • MalfunctionDec 13, 2017Break; Fracture; Fracture

    IT WAS REPORTED THAT; WHEN THE DOCTOR TIGHTENED THE CONNECTOR THE OPEN CONNECTOR WAS BROKEN. THEREFORE, IT WAS CHANGED TO A NEW ONE SAME SIZE AND THE OPERATION WAS COMPLETED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7112546 ↗
  • MalfunctionOct 10, 2016Difficult to Insert; Mechanical Problem; Difficult to Insert; Loose or Intermittent Connection; Mechanical Problem

    IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON INSERTED THE SCREWS TO L2-3(FIXATION EXTENDED). THE SURGEON USED THE ANGLED OPEN CONNECTOR. WHEN THE SURGEON TIGHTENED THE BLOCKER OF CONNECTOR, THE BLOCKER WAS NOT TIGHTENED. THEREFORE THE SURGEON CHANGED THE ANGLED OPEN CONNECTOR TO BRAND NEW CONNECTOR.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6015260 ↗

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Sources and updates

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