MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 8.5X90MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482804890
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device are currently unknown.
Event or Problem Description
It was reported that the head of an es2 integrated blade screw disengaged during final tightening.There were no adverse consequences to the patient and no surgical delays.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: once the necessary correction procedures have been performed and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed using the counter torque tube and the torque wrench.Place the counter torque tube down over the blades.Insert the torque wrench through the counter torque tube to engage the blocker.Turn the handle of the torque wrench clockwise to align the two arrows on the torque wrench to achieve the 12nm of torque required to secure the implant construct.Repeat the process for each blocker.Potential causes include: user error, blocker not correctly in tulip threads - too much torque applied (in excess of 12nm) - counter torque tube not used - cantilever force applied during final tightening - rod seated poorly in tulip - incorrect alignment of instrument to screw.H3 other text : device disposed.
Event or Problem Description
It was reported that the head of an es2 integrated blade screw disengaged during final tightening.There were no adverse consequences to the patient and no surgical delays.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 8.5X90MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9466734
• Report Number: 0009617544-2019-00136
• Device Sequence Number: 2513838
• Product Code: NKB
• UDI-Device Identifier: 07613327002522
• UDI-Public: 07613327002522
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 482804890
• Device Catalogue Number: 482804890
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1