MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.0 X 35; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48144035
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A health professional reported that four xia 4.5 polyaxial screws and four xia 4.5 blockers migrated post-operatively.The patient was revised approximately one month post-operatively.This report captures the fourth of four screws.
Additional Manufacturer Narrative
Additional data: d9, h3.Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.0 X 35
• 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: 23812690
• Report Number: 0009617544-2025-00120
• Device Sequence Number: 13255362
• Product Code: NKB
• UDI-Device Identifier: 04546540515193
• UDI-Public: (01)04546540515193(11)230425(10)232463
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/23/2026

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: 48144035
• Device Lot Number: 232463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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: Female
• Patient Weight: 25 KG