MAUDE Adverse Event Report: K2M, INC. CORPECTOMY CAGE WITH SET SCREW; SIZE 14X18MM, 32-46MM, 0°, 0-20°; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	7512-21846L0-G3
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A health professional reported that a patient was revised to address a capri corpectomy cage with set screws that migrated one month post-operatively.It was further reported that the patient complaint of pain.
Additional Manufacturer Narrative
Additional data: d9, h3.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: CORPECTOMY CAGE WITH SET SCREW; SIZE 14X18MM, 32-46MM, 0°, 0-20°
• 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: 24552829
• Report Number: 3004774118-2026-00082
• Device Sequence Number: 15799320
• Product Code: MQP
• UDI-Device Identifier: 10888857370784
• UDI-Public: (01)10888857370784(11)220630(10)WKJG-008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7512-21846L0-G3
• Device Lot Number: WKJG-008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown