MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48230000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately six years post-operatively to address a migrated xia 3 blocker which did not retain its respective rod post-operatively.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: XIA 3 TITANIUM 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: 21313375
• Report Number: 0009617544-2025-00011
• Device Sequence Number: 8151095
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: 04546540560193
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 48230000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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 Sex: Unknown