XIA II 03820645Recalls & reported problems

Stryker Corporation · MONOXIAL SCREW · Class 2 · Implant

All models of XIA II (34)

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

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 5
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540148919), received between Sep 7, 2016 and Aug 31, 2023 — classified as 5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Fracture6
Break3
Material Integrity Problem1

Patient problems

Injury3
Pain2
Failure of Implant1
No Clinical Signs, Symptoms or Conditions1
No Information1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

InjuryAug 31, 2023Fracture; Fracture
A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A FRACTURED XIA LP MONOAXIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17667180 ↗
InjuryNov 21, 2019Fracture; Fracture
A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A FRACTURED XIA LP MONOAXIAL SCREW. THE CONSTRUCT WAS REMOVED BUT THE BROKEN SHAFT OF THE SCREW COULD NOT BE EXPLANTED SINCE, "THE IMPLANT PLACE OF SCREW WAS VERY DEEP."
Patient problems: Injury
MAUDE report 9359879 ↗
MalfunctionJun 20, 2019Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL SURGERY MORE THAN ONE YEAR AGO FOR LUMBAR SPINE INJURY (INTERNAL FIXATION.) IT WAS REPORTED THAT THE PATIENT RECOVERED VERY WELL POST OPERATION. ON (B)(6) 2019 WHEN THE DOCTOR ARRANGED TO REMOVE THE PLATE, IT WAS NOTICED VIA X-RAY THAT A SCREW WAS FRACTURED. SINCE THE PATIENT HAD NO COMPLAINT OF DISCOMFORT, THE SURGEON MADE THE DECISION TO LEAVE THE FRACTURED SCREW IMPLANTED IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8718990 ↗
InjuryJun 13, 2018Break; Fracture; Fracture
IT WAS REPORTED THAT A SCREW WAS FOUND BROKEN POST OPERATIVELY. THE PATIENT HAD SPINAL FUSION SURGERY TWO AND A HALF YEARS AGO. PATIENT WAS REVISED TO REMOVE THE FRACTURED SCREW.
Patient problems: Failure of Implant; Injury
MAUDE report 7597826 ↗
InjuryMar 20, 2017Break; Fracture; Fracture
IT WAS REPORTED THAT; THE PATIENT WAS FOUND AS L4-5LDR IN 2015. THE DOCTOR INSERTED 4 6.5*45MM SCREWS AND 1 CAGE. ONE YEAR AFTER OPERATION, THE PATIENT FELT BACK PAIN, AND X-RAY SHOWED THE SCREW IS BROKEN. ONE SCREW'NECK IS BROKEN. DOCTOR NEEDS USE ANOTHER SCREW INSTEAD.
Patient problems: Injury; Pain
MAUDE report 6419437 ↗
InjurySep 7, 2016Break; Fracture; Fracture
IT WAS REPORTED THAT THE SCREW WAS BROKEN.
Patient problems: No Information; Pain
MAUDE report 5934188 ↗

Device details

UDI-DI	`04546540148919`
Brand	XIA II
Model	03820645
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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