MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM 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	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two xia rods fractured approximately four years post-operatively.Revision surgery has not taken place nor been scheduled.The patient was reported to have experienced an unknown serious adverse reaction.This report captures the second of two xia rods.
Additional Manufacturer Narrative
H6: coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported that two xia rods fractured approximately four years post-operatively.Revision surgery has not taken place nor been scheduled.The patient was reported to have experienced an unknown serious adverse reaction.This report captures the second of two xia rods.

• Brand Name: XIA 3 TITANIUM 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 20428344
• Report Number: 0009617544-2024-00127
• Device Sequence Number: 20937512
• Product Code: NKB
• UDI-Device Identifier: 04546540560575
• UDI-Public: (01)04546540560575(11)200116(10)6MK
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 6MK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2020
• 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: 13 YR
• Patient Sex: Female
• Patient Weight: 80 KG