MAUDE Adverse Event Report: K2M, Inc. MESA Spinal System Cricket; Orthopedic Manual Surgical Instrument

Catalog Number	6201-90084
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of a mesa jack cricket fractured intra-operatively and that the fractured tip remains in the patient.The procedure was completed successfully with a 10 minute surgical delay and no adverse consequence to the patient.On (b)(6) 2026, an additional fractured mesa cricket was returned and the fractured tip may have also remained in the patient.This report captures the second returned mesa cricket.

• Brand Name: MESA Spinal System Cricket
• 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: 50716455
• Report Number: 3004774118-2026-00240
• Device Sequence Number: 21482469
• Product Code: LXH
• UDI-Device Identifier: 10888857320468
• UDI-Public: 10888857320468
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 6201-90084
• Device Lot Number: THXM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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