MAUDE Adverse Event Report: STRYKER SPINE-US XIA ROD DIA. 6 X 400; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	03802400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent revision surgery approximately five years post-operatively to address a fractured mantis straight rod.
Event or Problem Description
It was reported that a patient underwent revision surgery approximately five years post-operatively to address a fractured xia rod.
Additional Manufacturer Narrative
Corrected data: b5, d1, d4, g4, h4.An updated device catalog number provided from the field indicates that this device is not approved for use in the us.Therefore, this event is no longer reportable to the fda.

• Brand Name: XIA ROD DIA. 6 X 400
• 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: 21309179
• Report Number: 0009617544-2025-00010
• Device Sequence Number: 18161660
• Product Code: NKB
• UDI-Device Identifier: 04546540671721
• UDI-Public: (01)04546540671721(11)161024(10)AWH
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 03802400
• Device Lot Number: AWH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2016
• 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