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

Model Number 482804890

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

Status and location of the device are currently unknown.

Event 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.

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 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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9466734
• MDR Text Key: 184158851
• Report Number: 0009617544-2019-00136
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327002522
• UDI-Public: 07613327002522
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482804890
• Device Catalogue Number: 482804890
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1