MAUDE Adverse Event Report: K2M, INC. CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 18-21MM, 0°, 0-20°; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	7512-21621L0-G3
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with pain was revised approximately 2 weeks post-operatively to address a corpectomy capri corpectomy cage with set screw whose initial expanded height had reduced.After removal of the cage it was revealed that the locking screw had not been tightened to the final torque.
Additional Manufacturer Narrative
Additional data: a3, d4, h4.H6 codes have been updated to reflect conclusion of the investigation.
Event or Problem Description
It was reported that a patient with pain was revised approximately 2 weeks post-operatively to address a corpectomy capri corpectomy cage with set screw whose initial expanded height had reduced.After removal of the cage it was revealed that the locking screw had not been tightened to the final torque.

• Brand Name: CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 18-21MM, 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19690108
• Report Number: 3004774118-2024-00056
• Device Sequence Number: 7156432
• Product Code: MQP
• UDI-Device Identifier: 10888857371071
• UDI-Public: (01)10888857371071(11)220419(17)270616(10)TRCU
• 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: 2024
• Device Explanted Year: 2024
• 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): 11/13/2024

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: 7512-21621L0-G3
• Device Lot Number: TRCU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2022
• 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: Female