MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM BLOCKER; THORACOLUMOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48230000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent revision surgery to address a "mechanical failure" between an es2 rod, an es2 integrated blade screw and a xia blocker five months post-operatively.Upon inspection of an additional returned xia 3 blocker, it was observed that this blocker also shows signs of migration.This report captures the second returned xia blocker.

• Brand Name: XIA 3 TITANIUM BLOCKER
• Common Device Name: THORACOLUMOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24544813
• Report Number: 0009617544-2026-00034
• Device Sequence Number: 5724806
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: (01)04546540560193(11)240918(10)KGR
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48230000
• Device Lot Number: KGR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown