MAUDE Adverse Event Report: STRYKER SPINE-US ES2 HEX RAD ROD 5.5 X 50MM; Thoracolumbosacral pedicle screw system

Catalog Number	482806050
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A health professional reported that a mantis redux blocker and an es2 rod migrated post-operatively.Revision surgery has not taken place nor been scheduled.No adverse consequences were reported.This report represents the es2 rod migration.
Event or Problem Description
The patient was revised.
Additional Manufacturer Narrative
Additional information: b2, b5, d4, h4.Corrected information: b1, h1.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: ES2 HEX RAD ROD 5.5 X 50MM
• 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 ; +1(201)760-8000
• MDR Report Key: 24682358
• Report Number: 0009617544-2026-00035
• Device Sequence Number: 13262902
• Product Code: NKB
• UDI-Device Identifier: 07613327001648
• UDI-Public: 07613327001648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/29/2026

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: 482806050
• Device Lot Number: KDT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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 Sex: Unknown