MAUDE Adverse Event Report: STRYKER SPINE-US 6.0X50 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482616050

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/25/2019

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was confirmed via x-ray a serrato screw fractured post operatively.The screw remains implanted in the patient.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned because it remains implanted in the patient.A review of the device history records and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.The serrato surgical technique outlines the steps for proper screw hole prep including awl, probe, and tap.If the screw holes are not properly prepped, and the screws are not fully inserted, this could case excess loading on the screw, which could cause the screw to fracture or disengage post operatively.The most likely root cause is inadequate screw hole prep/insertion caused by the patient's bone sclerosis.If a revision surgery is performed and the device becomes available, this investigation will be reopened and updated accordingly.

Event Description

It was confirmed via x-ray a serrato screw fractured post operatively.The screw remains implanted in the patient.

• Brand Name: 6.0X50 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9153300
• MDR Text Key: 195904869
• Report Number: 3005525032-2019-00079
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327352467
• UDI-Public: 07613327352467
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482616050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 65