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

Catalog Number	2112-90006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that one of the distal prongs on a capri inserter fractured off intra-operatively.The procedure was completed successfully with a 30 minute surgical delay and no adverse consequence to the patient.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional data: d4, d9, h3, h4.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: INSERTER
• 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: 22801008
• Report Number: 3004774118-2025-00129
• Device Sequence Number: 12963035
• Product Code: MQP
• UDI-Device Identifier: 10888857033634
• UDI-Public: (01)10888857033634(11)191009(10)JTMT
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 2112-90006
• Device Lot Number: JTMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2019
• 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