XIA 3 482316570Recalls & reported problems

Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant

All models of XIA 3 (93)

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540562289), received between Sep 12, 2018 and Sep 12, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

Device Dislodged or Dislocated1
Migration1

Patient problems

Injury1
No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 12, 2018Device Dislodged or Dislocated; Migration; Migration
IT WAS REPORTED THAT THE ILIAC BOLT IMPLANTED IN (B)(6) 2018 BACKED OUT/FAILED. THE ILIAC BOLT WAS REMOVED ON (B)(6) 2018. . OFFSET CONNECTOR AND SET SCREW WERE REMOVED ALSO.
Patient problems: Injury; No Code Available
MAUDE report 7870639 ↗

Device details

UDI-DI	`04546540562289`
Brand	XIA 3
Model	482316570
Company	Stryker Corporation
Product code	MNI · ORTHOSIS, SPINAL PEDICLE FIXATION
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.

Other ORTHOSIS, SPINAL PEDICLE FIXATION devices

NA 04.614.508
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277 reports
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CREO 1119.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
80 reports
VIPER 186731745
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
43 reports
CD HORIZON® Spinal System 1553201090
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
38 reports
EXPEDIUM 179902000
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
37 reports
CD HORIZON® Spinal System 7540220
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
36 reports
EXPEDIUM VERSE 199721640
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
35 reports

All ORTHOSIS, SPINAL PEDICLE FIXATION 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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