MAUDE Adverse Event Report: K2M, INC. CONTOURED ROD; SIZE Ø5.5X90 MM, TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	101-65590
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient was revised to address two denali straight deformity rods that migrated approximately five months post-operatively.This report captures the second of two rods.
Event or Problem Description
A company representative reported that a patient was revised to address one denali straight deformity rod and one denali contoured rod that migrated approximately five months post-operatively.This report captures the contoured rod.
Additional Manufacturer Narrative
Corrected data: b5, d4, g1.Additional data: d4, d9, h3, h4.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: CONTOURED ROD; SIZE Ø5.5X90 MM, TI
• 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24064056
• Report Number: 3004774118-2026-00015
• Device Sequence Number: 13044049
• Product Code: NKB
• UDI-Device Identifier: 10888857006911
• UDI-Public: (01)10888857006911(11)250408(10)2DYN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 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: 101-65590
• Device Lot Number: 2DYN
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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 Age: 51 YR
• Patient Sex: Female