MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48233600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent revision surgery to address an xia-3 titanium rod fracture.
Event or Problem Description
It was reported that a patient underwent revision surgery to address an xia-3 titanium rod fracture.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19392758
• Report Number: 0009617544-2024-00093
• Device Sequence Number: 7753723
• Product Code: NKB
• UDI-Device Identifier: 04546540560735
• UDI-Public: 04546540560735
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 48233600
• Device Lot Number: B3E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/14/2024
• 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