MAUDE Adverse Event Report: Stryker Spine-US XIA 3 ROD DIAM 6MM CP TI L 480MM; Thoracolumbosacral Pedicle Screw System

Catalog Number	48232480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient sustained a fall at home approximately 15 months post-operatively and experienced thoracic back pain.Imaging revealed that two xia 3 rods had fractured.The patient is scheduled to receive specialized medical care, however hospitalization nor surgical treatment have been required.This report captures the second of two rods.

• Brand Name: XIA 3 ROD DIAM 6MM CP TI L 480MM
• 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: 50074691
• Report Number: 0009617544-2026-00104
• Device Sequence Number: 10320628
• Product Code: NKB
• UDI-Device Identifier: 04546540560575
• UDI-Public: 04546540560575
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 48232480
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 132 LB
• Patient Race: White