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

Catalog Number	486613600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A health professional reported that a patient fell down on the street approximately two years and four monthly post-operatively and felt a "crunch" and severe pain in their spine.Additional imaging provided from the field indicated that three xia 3 rods fractured.It was further reported that revision surgery has been recommended, however it is unknown if a revision surgery has been scheduled or performed at this time.This report captures the third of three rods.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional data: d1, d4, g4.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: RADIUS ROD WITH HEX 5.5 X 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24972404
• Report Number: 0009617544-2026-00072
• Device Sequence Number: 14691021
• Product Code: NKB
• UDI-Device Identifier: 04546540545831
• UDI-Public: 04546540545831
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/11/2026
• 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
• Patient Sex: Unknown