MAUDE Adverse Event Report: K2M, INC. STRAIGHT ROD, DUAL HEX; SIZE Ø6.0X500 MM, TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	2901-B60500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that an everest rod fractured post-operatively.Additional detail is not available at this time.
Additional Manufacturer Narrative
Additional data: a2, a3a, b5, d1, d4, d6a, d6b, g4, h4.Corrected data: b1, b2, b3, h1.H6 coding has been updated to reflect additional information received.
Event or Problem Description
A company representative reported that a patient underwent revision surgery approximately one year post-operatively to address a fractured everest straight rod.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: STRAIGHT ROD, DUAL HEX; SIZE Ø6.0X500 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: 23528864
• Report Number: 3004774118-2025-00177
• Device Sequence Number: 21117303
• Product Code: NKB
• UDI-Device Identifier: 10888857040939
• UDI-Public: (01)10888857040939(11)221222(10)XVDN
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 02/20/2026

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-B60500
• Device Lot Number: XVDN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 01/26/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/17/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2022
• 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 Age: 58 YR
• Patient Sex: Female