MAUDE Adverse Event Report: KYOCERA MEDICAL TECHNOLOGIES, INC. KMTI S 150 STAND-ALONE ANTERIOR CERVIAL INTERBODY FUSION SYSTEM; ANTERIOR CERVICAL INTERBODY FUSION COVERPLATE

Model Number	S 150
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial surgery was completed on 11/23/2020.The complaint was reported to kmti after a routine follow-up examination (approximately 2 months).The patient was asymptomatic, but an x-ray revealed an unidentified piece of (likely) metallic debris in the vicinity of the coverplate.No further information is available other than the x-ray image showing the debris and the sales sheet.Kmti has attempted to contact the surgeon for additional information but has not received a response.At this time, it is unknown if revision surgery will be performed.If/when kmti receives further information on the patient, this portion of the investigation will be updated.Per the charge sheet, the surgery was performed on (b)(6) 2020.From the post-op x-ray image, the following information can be gathered: surgery was performed on two levels.This is a contraindication.The kmti ifu warns against excessive loading of the implant (potential risks, item 2).A two-level implantation can lead to excessive loading.For the first level (superior) the construct was oriented 1up/2 down (the two outboard screws were inserted into the inferior vertebra while the center screw was inserted into the superior vertebra).For the second level (inferior) the construct was oriented 1up/2 down.The second level construct shows the cage has subsided into the inferior endplate.
Event or Problem Description
During a routine follow-up examination, an x-ray revealed an unidentified piece of debris in the vicinity of the coverplate.

• Brand Name: KMTI S 150 STAND-ALONE ANTERIOR CERVIAL INTERBODY FUSION SYSTEM
• Common Device Name: ANTERIOR CERVICAL INTERBODY FUSION COVERPLATE
• Manufacturer (Section D): KYOCERA MEDICAL TECHNOLOGIES, INC.; 1200 california st.; suite 210; redlands CA 92374
• MDR Report Key: 11399951
• Report Number: 3015398319-2021-00001
• Device Sequence Number: 14608709
• Product Code: OVE
• UDI-Device Identifier: 00841523133963
• UDI-Public: (01)00841523133963(17)250221(10)13167-1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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: No Information
• Device Expiration Date: 02/21/2025
• Device Model Number: S 150
• Device Catalogue Number: 1050-003-004
• Device Lot Number: 13167-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1