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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A health professional reported that a xia 3 rod was observed to have fractured approximately 3 years and 8 months post-operatively.It was further reported that the event resulted in hospitalization or its extension.Revision surgery has not taken place nor been scheduled and the patient reported not experiencing any pain.

• 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 ; 2017608000
• MDR Report Key: 25898679
• Report Number: 0009617544-2026-00102
• Device Sequence Number: 5791357
• Product Code: NKB
• UDI-Device Identifier: 04546540560575
• UDI-Public: (01)04546540560575(11)210916(10)B9Z
• 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: 2022
• 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): 07/21/2026

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: 48232480
• Device Lot Number: B9Z
• 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: 06/24/2026
• Initial Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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: Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White