MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482804640
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent revision surgery to address a "mechanical failure" between an es2 rod, an es2 integrated blade screw and a xia blocker five months post-operatively.This report captures the es2 screw.
Additional Manufacturer Narrative
Corrected data: g1.Additional data: b5, d4, d9, h3, h4.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
Upon inspection of an additional returned xia 3 blocker, it was observed that the blocker showed signs of migration.This report captures the es2 screw.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 6.5X40MM
• 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: 23145096
• Report Number: 0009617544-2025-00078
• Device Sequence Number: 8944141
• Product Code: NKB
• UDI-Device Identifier: 07613327002171
• UDI-Public: (01)07613327002171(11)241017(10)248121
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/09/2026

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: 482804640
• Device Lot Number: 248121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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