MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6201-06540-G1
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of the investigations.Devices remain implanted.
Event or Problem Description
This report summarizes two malfunction events where a mesa screw migrated post-operatively.The patient "is not in severe pain so has been left and is still under surveillance".The devices remain implanted.
Event or Problem Description
This report summarizes two malfunction events where a mesa screw migrated post-operatively.The patient "is not in severe pain so has been left and is still under surveillance".The devices remain implanted.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual, dimensional, material and functional analysis could not be performed as the devices remain implanted.No further investigation for this event is possible at this time as insufficient information was received by stryker.If devices and/or additional information become available, this investigation will be reopened and updated.

• Brand Name: MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE 6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11747091
• Report Number: 3004774118-2021-00129
• Device Sequence Number: 14417080
• Product Code: NKB
• UDI-Device Identifier: 10888857263345
• UDI-Public: 10888857263345
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 6201-06540-G1
• Device Catalogue Number: 6201-06540-G1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1