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
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 second of two radius vitallium rods.
Additional Manufacturer Narrative
H3 other text : no product returned.
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 second 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: 19056052
• Report Number: 0009617544-2024-00034
• Device Sequence Number: 15461063
• 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