MAUDE Adverse Event Report: K2M, INC. INTERNAL EXPANSION TOWER; SIZE 24X30 MM, 8 MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	2112-20830
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A health professional reported that an endplate pin of a capri internal expansion tower disengaged post-operatively.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.
Additional Manufacturer Narrative
Corrected data: b5.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A health professional reported that an endplate pin of a capri internal expansion tower disengaged intra-operatively.This was observed in an intra-operative x-ray.The surgeon decided to leave the device implanted in the patient.No adverse consequences were reported.

• Brand Name: INTERNAL EXPANSION TOWER; SIZE 24X30 MM, 8 MM
• 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24552820
• Report Number: 3004774118-2026-00083
• Device Sequence Number: 13107875
• Product Code: MQP
• UDI-Device Identifier: 10888857033498
• UDI-Public: 10888857033498
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 2112-20830
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female