Xia 3 System - Serrato 482616550Recalls & reported problems

Stryker Corporation · Polyaxial Screw · Class 2 · Implant

All models of Xia 3 System - Serrato (36)

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

Adverse event reports: 9
Deaths reported: 0
Injuries reported: 7
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327351552), received between Mar 29, 2019 and Nov 14, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (5 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

Migration5
Appropriate Device Problem Term/Code Not Available2
Fracture2
Loose or Intermittent Connection2
Material Protrusion/Extrusion2
Unintended Movement2
Device Slipped1

Patient problems

Pain7
Injury6
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

InjuryNov 14, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY TWO YEARS POST-OPERATIVELY TO ADDRESS A MIGRATED XIA SERRATO POLYAXIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20690935 ↗
MalfunctionJan 27, 2023Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE FRACTURE OF TWO SERRATO SCREWS. THE PATIENT HAS NOT BEEN REVISED AND REVISION IS NOT CURRENTLY SCHEDULED. THIS REPORT CAPTURES THE FIRST OF TWO FRACTURED SCREWS.
Patient problems: Pain
MAUDE report 16258308 ↗
MalfunctionJan 27, 2023Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE FRACTURE OF TWO SERRATO SCREWS. THE PATIENT HAS NOT BEEN REVISED AND REVISION IS NOT CURRENTLY SCHEDULED. THIS REPORT CAPTURES THE SECOND OF TWO FRACTURED SCREWS.
Patient problems: Pain
MAUDE report 16258224 ↗
InjuryJul 9, 2019Migration
IT WAS REPORTED THAT A SCREW MIGRATED POST-OPERATIVELY. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. DURING REVISION SURGERY, THE SURGEON REMOVED THE SAME SCREW THAT WAS IMPLANTED INTO S1 AND RE-IMPLANTED AT A DIFFERENT ANGLE.
Patient problems: Injury
MAUDE report 8771793 ↗
InjuryMar 30, 2019Material Protrusion/Extrusion; Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH A LEG PAIN POST-OPERATIVELY. A POST-OP X-RAY SHOWED A COMPROMISED STRUCTURE AND POTENTIAL DISLODGEMENT OF THE CAGE. FURTHER COMMUNICATION WITH SALES REP AND CT SCAN REVIEW CONFIRMED THAT THE CAGE HAD NOT BEEN DISLODGED. AN X-RAY SHOWED THE SCREW HAS PROTRUDED THROUGH THE VERTEBRAL BODY INTO DISC SPACE. A REVISION SURGERY WAS PERFORMED TO REMOVE SCREW AND CONSTRUCT EXTENSION FROM L3-S1.
Patient problems: Injury; Pain
MAUDE report 8467486 ↗
InjuryMar 29, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Migration; Migration
IT WAS REPORTED THAT THE SCREW WAS FOUND TO BE LOOSE. THE PATIENT WAS IN PAIN AND REVISION SURGERY WAS PERFORMED FOR REPLACEMENT OF HARDWARE, UPSIZE SCREWS AND FUSE POSTERIOR LATERAL.
Patient problems: Injury; Pain
MAUDE report 8467390 ↗
InjuryMar 29, 2019Material Protrusion/Extrusion; Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH A LEG PAIN POST-OPERATIVELY. A POST-OP X-RAY SHOWED A COMPROMISED STRUCTURE AND POTENTIAL DISLODGEMENT OF CAGE. FURTHER COMMUNICATION WITH SALES REP AND CT SCAN REVIEW CONFIRMED THAT THE CAGE HAD NOT BEEN DISLODGED. AN X-RAY SHOWED THE SCREW HAS PROTRUDED THROUGH THE VERTEBRAL BODY INTO DISC SPACE. A REVISION SURGERY WAS PERFORMED TO REMOVE SCREW AND CONSTRUCT EXTENSION FROM L3-S1.
Patient problems: Injury; Pain
MAUDE report 8467389 ↗
InjuryMar 29, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Migration; Migration
IT WAS REPORTED THAT THE SCREW WAS FOUND TO BE LOOSE. THE PATIENT WAS IN PAIN AND REVISION SURGERY WAS PERFORMED FOR REPLACEMENT OF HARDWARE, UPSIZE SCREWS AND FUSE POSTERIOR LATERAL.
Patient problems: Injury; Pain
MAUDE report 8467159 ↗
InjuryMar 29, 2019Device Slipped; Migration; Migration
IT WAS REPORTED THAT THE SCREW WAS FOUND TO BE LOOSE. THE PATIENT WAS IN PAIN AND REVISION SURGERY WAS PERFORMED FOR REPLACEMENT OF HARDWARE, UPSIZE SCREWS AND FUSE POSTERIOR LATERAL.
Patient problems: Injury; Pain
MAUDE report 8467120 ↗

Device details

UDI-DI	`07613327351552`
Brand	Xia 3 System - Serrato
Model	482616550
Company	Stryker Corporation
Product code	NKB · Thoracolumbosacral pedicle screw system
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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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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