MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 55 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482317555
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with significant back pain underwent revision surgery to address a bilateral tulip disengagement of two xia polyaxial screws.This report captures the second of two screws.
Additional Manufacturer Narrative
Additional data: h3 h6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 55 MM
• 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: 22778225
• Report Number: 0009617544-2025-00068
• Device Sequence Number: 18421963
• Product Code: NKB
• UDI-Device Identifier: 04546540562371
• UDI-Public: (01)04546540562371(11)080523(10)A81750
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 482317555
• Device Lot Number: A81750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2008
• 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 Age: 61 YR
• Patient Sex: Male