MAUDE Adverse Event Report: K2M, INC. EVEREST Spinal System Curved Thoracic Probe, Handle w/Impactor Size Ø2.0¿; Orthopedic Manual Surgical Instrument

Catalog Number	2901-90033
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of an everest curved thoracic probe, handle with impactor cap fractured intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: EVEREST Spinal System Curved Thoracic Probe, Handle w/Impactor Size Ø2.0¿
• Common Device Name: Orthopedic Manual Surgical Instrument
• Manufacturer (Section D): K2M, INC.; 600 hope pkwy; leesburg VA 20175
• Manufacturer (Section G): K2M, Inc.; 600 hope pkwy se; leesburg VA 20175
• Manufacturer Contact: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; +1(201)760-8000
• MDR Report Key: 25630919
• Report Number: 3004774118-2026-00177
• Device Sequence Number: 9562281
• Product Code: LXH
• UDI-Device Identifier: 10888857040007
• UDI-Public: (01)10888857040007(11)200527(10)MEGV
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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: 2901-90033
• Device Lot Number: MEGV
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown