MAUDE Adverse Event Report: K2M, INC. CONTOURED ROD; SIZE Ø5.5X60 MM, TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	101-65560
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that a patient underwent revision surgery to address a fractured denali contoured rod and a migrated unknown cage.The patient reported experiencing pain.This report captures the denali rod.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: CONTOURED ROD; SIZE Ø5.5X60 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23124962
• Report Number: 3004774118-2025-00141
• Device Sequence Number: 9287599
• Product Code: NKB
• UDI-Device Identifier: 10888857006799
• UDI-Public: (01)10888857006799(11)220428(10)THNB
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 01/08/2026

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: 101-65560
• Device Lot Number: THNB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown