MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802745
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	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one week post-operatively, imaging revealed that the tulip of an es2 integrated blade screw had disengaged from the shaft at left t11.Currently there is no plan to revise the patient.
Additional Manufacturer Narrative
Corrected data: g1 h6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
It was reported that one week post-operatively, imaging revealed that the tulip of an es2 integrated blade screw had disengaged from the shaft at left t11.Currently there is no plan to revise the patient.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
• 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: 20725372
• Report Number: 0009617544-2024-00181
• Device Sequence Number: 9161824
• Product Code: NKB
• UDI-Device Identifier: 07613327002010
• UDI-Public: 07613327002010
• 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): 03/10/2025

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: 482802745
• Device Lot Number: ONE OF 244520, 224520, 237140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 03/10/2025
• 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 Sex: Male
• Patient Weight: 50 KG