MAUDE Adverse Event Report: K2M, INC. INSERTER THREADED SHAFT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	2112-90009
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that two capri inserter threaded shafts deformed intra-operatively during cage insertion.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This record captures the first capri inserter threaded shaft.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional data: h3.H6 coding has been updated to reflect investigation conclusion.

• Brand Name: INSERTER THREADED SHAFT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 21368262
• Report Number: 3004774118-2025-00024
• Device Sequence Number: 15583300
• Product Code: MQP
• UDI-Device Identifier: 10888857033665
• UDI-Public: (01)10888857033665(11)141218(10)DBAEA
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K142016
• 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): 05/29/2025

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: 2112-90009
• Device Lot Number: DBAEA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2014
• 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