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

Catalog Number	486613602
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : no product returned.
Event or Problem Description
It was reported that approximately 8 years post-operatively, imaging revealed a xia polyaxial screw tip fracture and the fracture of two radius vitallium rods.This report captures the first of two radius vitallium rods.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported that approximately 8 years post-operatively, imaging revealed a xia polyaxial screw tip fracture and the fracture of two radius vitallium rods.This report captures the first of two radius vitallium rods.

• Brand Name: RADIUS VITALLIUM ROD 5.5 X 600 MM W/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: 19056054
• Report Number: 0009617544-2024-00035
• Device Sequence Number: 15461065
• Product Code: NKB
• UDI-Device Identifier: 04546540604859
• UDI-Public: 04546540604859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 07/17/2024

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: 486613602
• Device Lot Number: HXB
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2014
• 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: 22 YR
• Patient Sex: Female
• Patient Weight: 49 KG