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

Catalog Number	482616050
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was confirmed via x-ray a serrato screw fractured post operatively.The screw remains implanted in the patient.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9153300
• Report Number: 3005525032-2019-00079
• Device Sequence Number: 2132670
• Product Code: NKB
• UDI-Device Identifier: 07613327352467
• UDI-Public: 07613327352467
• Combination Product (Y/N): N
• PMA/510(K) Number: K170496
• 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): 11/27/2019

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: 482616050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65