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

Catalog Number	482802640
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	01/09/2026
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.
Event or Problem Description
Upon inspection of the returned device, it was observed that a tab of the screw was fractured and that the tulip of the screw was still intact.
Additional Manufacturer Narrative
Corrected data: b5.Additional data: d9, h3.Upon inspection of the returned device, it was observed that a tab of the screw was fractured and that the tulip of the screw was still intact.An updated review of the event information and risk documentation regarding this event does not suggest a recurrence of this event could result in a death or serious injury.Therefore, this event is no longer reportable to the fda.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 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: 24281724
• Report Number: 0009617544-2026-00005
• Device Sequence Number: 9963169
• Product Code: NKB
• UDI-Device Identifier: 07613327001938
• UDI-Public: (01)07613327001938(11)250911(10)257970
• 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): 02/13/2026

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: 482802640
• Device Lot Number: 257970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 60 KG