MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø5.5X30 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	6201-05530-G1
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a mesa 2 polyaxial screw was difficult to final lock intra-operatively and that the screw pin disengaged.It was further reported that the screw migrated intra-operatively.The device was subsequently removed from the patient and the surgeon decided to leave left-side t2 without a screw inserted.The procedure was completed with a 10 minute surgical delay.
Additional Manufacturer Narrative
Additional data: d4, d9, h3, h4 h6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø5.5X30 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: 22469306
• Report Number: 3004774118-2025-00114
• Device Sequence Number: 20861305
• Product Code: NKB
• UDI-Device Identifier: 10888857262942
• UDI-Public: (01)10888857262942(11)220202(10)TJWC
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 6201-05530-G1
• Device Lot Number: TJWC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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 Sex: Unknown