MAUDE Adverse Event Report: K2M, INC. CURVED THORACIC PROBE, HANDLE W/IMPACTOR CAP; SIZE Ø2.0"; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	2901-90033
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that the tip of an everest curved thoracic probe fractured off intra-operatively and remains implanted in the patient at s1.It was further reported that the procedure was completed successfully by inserting an additional screw at s2.
Additional Manufacturer Narrative
Additional data: h3.H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
No new information.

• Brand Name: CURVED THORACIC PROBE, HANDLE W/IMPACTOR CAP; SIZE Ø2.0"
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 22069984
• Report Number: 3004774118-2025-00088
• Device Sequence Number: 18318607
• Product Code: LXH
• UDI-Device Identifier: 10888857040007
• UDI-Public: (01)10888857040007(11)221115(10)UDJN
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 2901-90033
• Device Lot Number: UDJN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male