XIA 3 48230133Recalls & reported problems

Stryker Corporation · LONG OFFSET CONNECTOR · Class 2 · Implant

All models of XIA 3 (93)

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540602282), received between Sep 16, 2016 and Aug 24, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Device problems

Fracture3
Break2
Material Integrity Problem2

Patient problems

Injury2
Laceration(s)1
No Information1
No Known Impact Or Consequence To Patient1
Perforation1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 24, 2018Fracture
UPON FINAL TIGHTENING OF A SET SCREW OF THE OFFSET CONNECTOR, THE SET SCREW FRACTURED. THE OFFSET CONNECTOR WAS REPLACED WITH ANOTHER SAME NEW ONE.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 7812388 ↗
MalfunctionSep 19, 2016Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; ON (B)(6) 2016, SURGERY WAS PERFORMED FOR SPINAL DEFORMITY DUE TO PARKINSON'S DISEASE. T5 - ILIAC WERE FIXED AND THE ROD CONNECTORS WERE USED FOR ILIAC. AFTER THAT, THE ROD CONNECTORS BROKE AND THE ROD PERFORATED THE SKIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. EXCHANGE AND ADDING OF ILIAC SCREW HAS DONE. THE BLOCKER WHICH INSERTED THE RIGHT ILIAC SCREW WAS LOOSE
Patient problems: Injury; Laceration(s)
MAUDE report 5959462 ↗
InjurySep 16, 2016Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; ON (B)(6) 2016, SURGERY WAS PERFORMED FOR SPINAL DEFORMITY DUE TO PARKINSON'S DISEASE. T5 - ILIAC WERE FIXED AND THE ROD CONNECTORS WERE USED FOR ILIAC. AFTER THAT, THE ROD CONNECTORS BROKE AND THE ROD PERFORATED THE SKIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. EXCHANGE AND ADDING OF ILIAC SCREW HAS DONE. THE BLOCKER WHICH INSERTED THE RIGHT ILIAC SCREW WAS LOOSE.
Patient problems: Injury; Perforation
MAUDE report 5957735 ↗

Device details

UDI-DI	`04546540602282`
Brand	XIA 3
Model	48230133
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): Bone-screw internal spinal fixation system connector

An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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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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