MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48232601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that a xia 3 rod fractured intra-operatively.The procedure was completed with no surgical delay.It was further reported that the patient experienced increased bleeding and that this may not be related to the event.
Additional Manufacturer Narrative
Additional data: b5, h3.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was further reported that there was a 10-15 minute surgical delay and that the patient is doing well.

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
• 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: 23480460
• Report Number: 0009617544-2025-00087
• Device Sequence Number: 13318917
• Product Code: NKB
• UDI-Device Identifier: 04546540608642
• UDI-Public: (01)04546540608642(11)240826(10)K3T
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113666
• 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): 01/08/2026

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: 48232601
• Device Lot Number: K3T
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian