MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 BLOCKER; Thoracolumbosacral Pedicle Screw System

Catalog Number	48230000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A health professional reported that a patient was revised approximately three weeks post-operatively to address a migrated xia 3 blocker.The patient reported experiencing a "clicking" sound during movement and x-ray imaging revealed the migration.

• Brand Name: XIA 3 BLOCKER
• Common Device Name: Thoracolumbosacral 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 ; +1(201)760-8000
• MDR Report Key: 25437549
• Report Number: 0009617544-2026-00090
• Device Sequence Number: 13285706
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: (01)04546540560193(11)210528(10)YBK
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: YBK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• 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