MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 4.5X25MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802425
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that an es2 integrated blade screw migrated about 2.5mm into the spinal canal post-operatively.The patient does not have subjective symptoms at this time, but the surgeon may revise in the future.
Event or Problem Description
It was reported that an es2 integrated blade screw migrated about 2.5mm into the spinal canal post-operatively.The patient is asymptomatic at this time, but the surgeon may revise in the future.This report represents the right side t3 screw.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device remains implanted in patient.A review of the device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained.From es2 surgical technique: imaging should be used to confirm desired placement of screw.Since no further information is available, an exact root cause of reported event could not be determined but most likely due to user error.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 4.5X25MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9862619
• Report Number: 0009617544-2020-00045
• Device Sequence Number: 3332190
• Product Code: NKB
• UDI-Device Identifier: 07613327001815
• UDI-Public: 07613327001815
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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 Model Number: 482802425
• Device Catalogue Number: 482802425
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/30/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1