MAUDE Adverse Event Report: STRYKER SPINE-US XIA BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	03756230
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised to address a fractured xia rod and a migrated unknown set screw.This report captures the unknown set screw.
Event or Problem Description
It was reported that a patient was revised to address a fractured xia rod and a migrated xia blocker.This report captures the xia blocker.
Additional Manufacturer Narrative
Additional data: b5, d1, d4, d9, g4, h3, h4.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: XIA 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 21980885
• Report Number: 0009617544-2025-00038
• Device Sequence Number: 18367346
• Product Code: NKB
• UDI-Device Identifier: 04546540147257
• UDI-Public: (01)04546540147257(11)100906(10)UNL
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/16/2025

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: 03756230
• Device Lot Number: UNL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2010
• 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