MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 8.5X70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802870
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health professional reported that the tulip of an es2 integrated blade screw disengaged intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Additional data: d9, h3, h4.Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 8.5X70MM
• 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: 23874120
• Report Number: 0009617544-2025-00131
• Device Sequence Number: 5546676
• Product Code: NKB
• UDI-Device Identifier: 07613327002539
• UDI-Public: (01)07613327002539(11)231120(10)237141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 482802870
• Device Lot Number: 237141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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: Female