MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X80 MM; THORACOLUMOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	2901-08580G
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient was revised to address an everest polyaxial screw tulip disengagement.It was further reported that the patient experienced discomfort.
Additional Manufacturer Narrative
Corrected data: b3.Additional communication from the field was received that indicates that the g3 date provided in the initial report should have been 01/29/2026.
Event or Problem Description
No new information.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional data: d4, h3, h4.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X80 MM
• Common Device Name: THORACOLUMOSACRAL 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24436680
• Report Number: 3004774118-2026-00047
• Device Sequence Number: 10304275
• Product Code: NKB
• UDI-Device Identifier: 10888857037663
• UDI-Public: (01)10888857037663(11)241206(10)WFCC
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2901-08580G
• Device Lot Number: WFCC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 03/09/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/05/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown