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.Imaging indicated that two 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 second of two rods.
Additional Manufacturer Narrative
Additional data: b5, d1, d4, g4.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
Additional imaging provided from the field indicated that three rods fractured.This report captures the second of three rods.

• 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: 24877575
• Report Number: 0009617544-2026-00069
• Device Sequence Number: 21307113
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/14/2026
• 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