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

Model Number	486613602
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported a fractured radius vitallium rod on the right side of their construct.Imaging shows the fractured device has migrated and patient reports that they are ambulatory but in pain.Revision surgery is not currently planned.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A patient reported a fractured radius vitallium rod on the right side of their construct.Imaging shows the fractured device has migrated and patient reports that they are ambulatory but in pain.Revision surgery is not currently planned.

• 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: 16862848
• Report Number: 0009617544-2023-00020
• Device Sequence Number: 5385587
• Product Code: NKB
• UDI-Device Identifier: 04546540604859
• UDI-Public: 04546540604859
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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 Model Number: 486613602
• Device Catalogue Number: 486613602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 91 KG