MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802740
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a titanium pl cage and an es2 screw migrated post-operatively.It was further reported that a revision surgery will be performed.This report captures the screw.
Additional Manufacturer Narrative
Additional data: b5, d6a h6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported that a patient was revised to address a tritanium pl cage and an es2 screw that migrated post-operatively.It was further reported that during the revision surgery, it was observed that two additional es2 screws migrated post-operatively.It was further reported that the patient was working in the fields one month post-operatively.This report captures the screw that was being revised.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM
• 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 21306167
• Report Number: 0009617544-2025-00009
• Device Sequence Number: 15491643
• Product Code: NKB
• UDI-Device Identifier: 07613327002003
• UDI-Public: (01)07613327002003(11)240219(10)240989
• 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: 2024
• 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): 04/17/2025

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: 482802740
• Device Lot Number: 240989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 04/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• 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 Age: 75 YR
• Patient Sex: Female