MAUDE Adverse Event Report: K2M, INC. INTERNAL EXPANSION TOWER; SIZE 28X36 MM, 8 MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	2112-20836
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implantation and expansion, the port in the capri internal expansion tower was stripped and the tower could not expand.The implant was taken out of the body and another capri internal expansion tower was used to successfully complete the procedure with a surgical delay of 20 minutes and no adverse consequence to the patient.
Event or Problem Description
It was reported that during the implantation and expansion, the port in the capri internal expansion tower was stripped and the tower could not expand.The implant was taken out of the body and another capri internal expansion tower was used to successfully complete the procedure with a surgical delay of 20 minutes and no adverse consequence to the patient.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.

• Brand Name: INTERNAL EXPANSION TOWER; SIZE 28X36 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15653541
• Report Number: 3004774118-2022-00362
• Device Sequence Number: 6036844
• Product Code: MQP
• UDI-Device Identifier: 10888857033504
• UDI-Public: 10888857033504
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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 Model Number: 2112-20836
• Device Catalogue Number: 2112-20836
• Device Lot Number: GVBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2018
• 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 Sex: Unknown