MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 8.5X80MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802880
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an es2 integrated blade screw fractured post-operatively.No adverse consequences were reported.The fractured screw was observed in a planned revision surgery for rod reinforcement approximately 8.5 years post-operatively.The screw tulip was explanted, however the screw shank remains implanted in the patient.
Event or Problem Description
It was reported that an es2 integrated blade screw fractured post-operatively.No adverse consequences were reported.The fractured screw was observed in a revision surgery (addressed in 0009617544-2025-00048) approximately 8.5 years post-operatively.The screw tulip was explanted, however the screw shank remains implanted in the patient.
Additional Manufacturer Narrative
Additional data: b5 h6 coding has been updated to reflect investigation conclusion.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 8.5X80MM
• 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: 21857938
• Report Number: 0009617544-2025-00032
• Device Sequence Number: 4695798
• Product Code: NKB
• UDI-Device Identifier: 07613327002546
• UDI-Public: 07613327002546
• 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: 2016
• Device Explanted Year: 2025
• 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): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482802880
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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 Age: 66 YR
• Patient Sex: Male