XIA 4 5 481322070Recalls & reported problems

Stryker Corporation · VITALLIUM PREBENT AND PRECUT ROD WITH HEX · Class 2 · Implant

All models of XIA 4 5 (32)

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

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327002614), received between Dec 6, 2016 and Mar 7, 2017 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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

Mechanical Problem4
Unintended Movement4
Device Dislodged or Dislocated2
Device Slipped2
Migration or Expulsion of Device2

Patient problems

Injury2
No Code Available2
No Known Impact Or Consequence To Patient2
Pain2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

InjuryMar 7, 2017Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT; RODS ON BOTH SIDES MOVED. THE BLOCKERS STAYED WITHIN THE TULIP HEADS. WE PUT IN NEW RODS AND NEW BLOCKERS.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6384225 ↗
MalfunctionMar 7, 2017Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT; RODS ON BOTH SIDES MOVED. THE BLOCKERS STAYED WITHIN THE TULIP HEADS. WE PUT IN NEW RODS AND NEW BLOCKERS.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 6384222 ↗
InjuryDec 6, 2016Mechanical Problem; Unintended Movement; Mechanical Problem; Migration or Expulsion of Device; Device Slipped; Unintended Movement
IT WAS REPORTED THAT ON TUESDAY (B)(6) THE DOCTOR SAW A POST OP PATIENT IN HIS OFFICE. BASED ON X RAY, HE FEELS CONCERNED THAT THE PATIENT HAS EXPERIENCED AN IMPLANT RELATED POST OP EVENT. IN SURGEONS WORDS, "HARDWARE HAS APPEARED TO HAVE SHIFTED. ROD SEEMS TO HAVE SLIPPED BENEATH A SET SCREW."
Patient problems: Injury; No Code Available
MAUDE report 6147574 ↗
MalfunctionDec 6, 2016Mechanical Problem; Unintended Movement; Mechanical Problem; Migration or Expulsion of Device; Device Slipped; Unintended Movement
IT WAS REPORTED THAT ON TUESDAY (B)(6) THE DOCTOR SAW A POST OP PATIENT IN HIS OFFICE. BASED ON X RAY, HE FEELS CONCERNED THAT THE PATIENT HAS EXPERIENCED AN IMPLANT RELATED POST OP EVENT. IN SURGEONS WORDS, "HARDWARE HAS APPEARED TO HAVE SHIFTED. ROD SEEMS TO HAVE SLIPPED BENEATH A SET SCREW."
Patient problems: Injury; No Code Available
MAUDE report 6147565 ↗

Device details

UDI-DI	`07613327002614`
Brand	XIA 4 5
Model	481322070
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	Jun 14, 2024

Device type (GMDN): Bone-screw internal spinal fixation system rod

An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder 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)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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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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