MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X40 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482616540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital retained device.
Event or Problem Description
It was reported that the surgeon implanted two serrato polyaxial screws as intended and found upon insertion that the l5 left sided and right sided pedicles fractured upon insertion.Patient experienced bone damage.This report represents the 2nd of the 2 screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.From the serrato surgical technique: for increased bone purchase, use the taps to prepare the pedicle canal.After attaching a xia 3 handle, insert the tap into the pedicle and into the vertebral body.With the pedicle pathway prepared, and the proper screw diameter and length determined, insert the screw into the pedicle using the appropriate screwdriver.The serrato polyaxial titanium self-tapping screws have serrations to ease screw insertion.However, in most cases, tapping is recommended.Possible root causes include lack of tapping, undertapping, difficult angle, and/or excess torque applied.
Event or Problem Description
It was reported that the surgeon implanted two serrato polyaxial screws as intended and found upon insertion that the l5 left sided and right sided pedicles fractured upon insertion.Patient experienced bone damage.This report represents the 2nd of the 2 screws.

• Brand Name: 6.5X40 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9819845
• Report Number: 3005525032-2020-00019
• Device Sequence Number: 19274304
• Product Code: NKB
• UDI-Device Identifier: 07613327351958
• UDI-Public: 07613327351958
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 482616540
• Device Catalogue Number: 482616540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other