MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE 8.5X90 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2901-08590G
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reported that two everest spinal system polyaxial screws, closed; size ø7.5x80 mm and closed; size ø8.5x90 mm, "broke" during revision surgery.Surgery was successfully completed with a 20 minute delay.No adverse consequences or medical intervention were reported.This report captures the second of two screws.
Additional Manufacturer Narrative
D.4.Lot has been updated with received lot number.
Event or Problem Description
Physician reported that two everest spinal system polyaxial screws "broke" during revision surgery.Surgery was successfully completed with a 20 minute delay.No adverse consequences or medical intervention were reported.This report captures the second of two screws.
Additional Manufacturer Narrative
Visual inspection: it was observed that the polyaxial screw tulip was disengaged from the screw shank.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Everest implants are designed for use with everest surgical instruments.The everest implants comply with the standards applicable to the everest material composition.Using a non-stryker driver with the everest polyaxial screw is contraindicated in the product labeling.Other contributing factors may be using excess torque as well as reversing and taking out the screw to adjust.The root cause of the screw fracture is determined to be contraindicated usage of a non-stryker instrument during surgery.
Event or Problem Description
Physician reported that two everest spinal system polyaxial screws "broke" during revision surgery.Surgery was successfully completed with a 20 minute delay.No adverse consequences or medical intervention were reported.Upon inspection of the returned device, the screw tulip was disengaged from the screw shank.This report captures the second of two screws.

• Brand Name: POLYAXIAL SCREW, CLOSED; SIZE 8.5X90 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10077570
• Report Number: 3004774118-2020-00095
• Device Sequence Number: 3815826
• Product Code: NKB
• UDI-Device Identifier: 10888857037700
• UDI-Public: 10888857037700
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140529
• 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,Followup
• Report Date (Section B): 08/21/2020

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: 2901-08590G
• Device Catalogue Number: 2901-08590G
• Device Lot Number: EAYU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 06/17/2020; 07/25/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/15/2020; 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1