MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 ROD DIAM 6MM CP TI L 480MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48232480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A health professional reported that an unknown rod fractured intra-operatively and that the patient experienced unspecified adverse consequences.
Event or Problem Description
The procedure was completed with a 20 minute surgical delay.
Additional Manufacturer Narrative
Additional information: b5, d1, d4, d9, h3, h4 h6 coding has been updated to reflect completion of the investigation.

• Brand Name: XIA 3 ROD DIAM 6MM CP TI L 480MM
• 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23882515
• Report Number: 0009617544-2025-00136
• Device Sequence Number: 20010327
• Product Code: NKB
• UDI-Device Identifier: 04546540560575
• UDI-Public: 04546540560575
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

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: 48232480
• Device Lot Number: N8S
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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