XIA 3 482317555Recalls & reported problems

Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant

All models of XIA 3 (93)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540562371), received between Oct 25, 2016 and Aug 11, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break3
Device Dislodged or Dislocated3
Detachment of Device or Device Component2
Fracture2
Material Integrity Problem2
Mechanical Problem1

Patient problems

Injury2
Pain2
Device Embedded In Tissue or Plaque1
No Code Available1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

InjuryAug 11, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO NEW INFORMATION.
Patient problems: Pain
MAUDE report 22778226 ↗
InjuryAug 11, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO NEW INFORMATION.
Patient problems: Pain
MAUDE report 22778225 ↗
MalfunctionFeb 28, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; IMPLANTATION OF SCREW (B)(4) IN VERTEBRAL BODY S1, DURING REVISION SURGERY (B)(6) 2016 WITH ENLARGEMENT SPONDYLODESES CRANIAL, INSERTING NEW SIDE RAIL TO VERTEBRAL BODY S1, SCREWS REMAINED IN VERTEBRAL BODY. ACTUAL BROKEN SCREWS WERE DETECTED BOTH-SIDED IN S1. CLINICAL ROOT CAUSE MOST LIKELY TO PSEUDOARTHROSES L5/S1 DUE TO NOT HEALED CAGE IN SPINAL DISK SHELF L5/S1. CONSPICUOUS IS THE BREAK OF SCREWS BOTH-SIDED. BOTH SCREWS ARE FROM THE SAME LOT, THE HEADS OF SCREWS WERE REMOVED FOR EXHIBIT, THE BROKEN SCREW RESTS REMAIN IN VERTEBRAL BODY; NEW SCREWS WERE PLACED. HANDLING SCREWS EVERY TIME CORRESPONDING TO MANUFACTURERS´ INSTRUCTIONS.
Patient problems: Device Embedded In Tissue or Plaque; Injury
MAUDE report 6367302 ↗
InjuryFeb 28, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; IMPLANTATION OF SCREW (B)(6) 2016 IN VERTEBRAL BODY S1, DURING REVISION SURGERY (B)(6) 2016 WITH ENLARGEMENT SPONDYLOSDESE CRANIAL, INSERTING NEW SIDE RAIL TO VERTEBRAL BODY S1, SCREWS REMAINED IN VERTEBRAL BODY. ACTUAL BROKEN SCREWS WERE DETECTED BOTH-SIDED IN S1. CLINICAL ROOT CAUSE MOST LIKELY TO PSEUDOARTHROSE L5/S1 DUE TO NOT HEALED CAGE IN SPINAL DISK SHELF L5/S1. CONSPICUOUS IS THE BREAK OF SCREWS BOTH-SIDED. BOTH SCREWS ARE FROM THE SAME LOT, THE HEADS OF SCREWS WERE REMOVED FOR EXHIBIT, THE BROKEN SCREW RESTS REMAIN IN VERTEBRAL BODY; NEW SCREWS WERE PLACED. HANDLING SCREWS EVERY TIME CORRESPONDING TO MANUFACTURERS´ INSTRUCTIONS.
Patient problems: Injury; No Code Available
MAUDE report 6367301 ↗
MalfunctionOct 25, 2016Mechanical Problem; Break; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT A SCREW POTENTIALLY DAMAGED INTEROPERATIVELY, PREVENTING USE. THE HEAD OF THE SCREW WAS DISCOVERED BY SURGEON DISLODGED FROM THE SHAFT. SCREW WAS REMOVED AND REPLACED WITH SIMILAR SCREW FROM SAME SYSTEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6055206 ↗

Device details

UDI-DI	`04546540562371`
Brand	XIA 3
Model	482317555
Company	Stryker Corporation
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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