MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø4.5X30 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	6201-04530
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a mesa 2 polyaxial screw did not final lock properly intra-operatively, and that the rod was able to rotate slightly in the screw head after final locking.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.It was further reported that the surgeon was not satisfied with the correction achieved.
Event or Problem Description
It was reported that a mesa 2 polyaxial screw did not final lock properly intra-operatively, and that the rod was able to rotate slightly in the screw head after final locking.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.It was further reported that the surgeon was not satisfied with the correction achieved.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø4.5X30 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 20529343
• Report Number: 3004774118-2024-00097
• Device Sequence Number: 7984160
• Product Code: NKB
• UDI-Device Identifier: 10888857162976
• UDI-Public: 10888857162976
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 6201-04530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Female