MAUDE Adverse Event Report: Stryker Spine-US ES2 INTGRTD BLAD SCRW L 7.5X55MM; Thoracolumbosacral Pedicle Screw System

Catalog Number	482804755
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tulip of an es2 integrated blade screw disengaged intra-operatively and that the screw was removed and replaced during the procedure.The procedure was completed successfully with a 20-minute surgical delay and no adverse consequence to the patient.

• Brand Name: ES2 INTGRTD BLAD SCRW L 7.5X55MM
• 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 ; +1(201)760-8000
• MDR Report Key: 50869301
• Report Number: 0009617544-2026-00137
• Device Sequence Number: 9380254
• Product Code: NKB
• UDI-Device Identifier: 07613327002386
• UDI-Public: 07613327002386
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 482804755
• Device Lot Number: 193482
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2019
• 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: Unknown