MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS 5.5 X 600MM SPINAL ROD WITH HEX; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	486613600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Health authority russia reported that a patient with pain is to be revised approximately 3 years post-operatively to address three fractured rods.This report captures the radius spinal rod.

• Brand Name: RADIUS 5.5 X 600MM SPINAL ROD WITH HEX
• 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: 21025600
• Report Number: 0009617544-2024-00207
• Device Sequence Number: 15501728
• Product Code: NKB
• UDI-Device Identifier: 04546540545831
• UDI-Public: (01)04546540545831(11)210827(10)B5X
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: 486613600
• Device Lot Number: B5X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2021
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 70 KG