MAUDE Adverse Event Report: KYOCERA MEDICAL TECHNOLOGIES, INC. KYOCERA MEDICAL TECHNOLOGIES, INC.; TESERA ST LUMBAR INTERBODY IMPLANT

Model Number	S 141
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An expired implant was used in surgery on (b)(6) 2023.The implant expired on (b)(6) 2023.During the procedure, the sales representative notified the surgeon of the expired implant; however, the surgeon was comfortable with leaving the implant in the patient.
Additional Manufacturer Narrative
As reported, an expired implant was inadvertently implanted into the patient.There has been no reported patient injury/infection to date.No revision surgery was reported.The expiration date is located on multiple layers of the packaging.This event is confirmed as a user related error with no malfunction of the device.A review of manufacturing records confirms the product was manufactured to specification and there is no indication of a product quality issue with respect to design, manufacturing, or labeling.The product remains implanted in the patient and will not be revised/returned.An internal capa was opened to address expired or expiring inventory consigned with independent sales representatives.Kmti will test expired packages from the same or similar lots to verify if the package retained sufficient seal strength and seal integrity post expiration.Based on previous testing performed by kmti on other expired package(s) it is most likely the expired package(s) testing will show the package(s) did retain sufficient seal strength and seal integrity for at least one month post expiration.The seal testing will be performed within the next thirty days.Results, when they are available, will be recorded within the kmti internal capa process.If the results show sufficient seal strength and seal integrity, no supplemental mdr will be submitted.If the results show compromised seal strength and seal integrity, a supplemental mdr will be submitted.Should additional information be provided by the healthcare provider, a supplemental mdr will be submitted.

• Brand Name: KYOCERA MEDICAL TECHNOLOGIES, INC.
• Common Device Name: TESERA ST LUMBAR INTERBODY IMPLANT
• Manufacturer (Section D): KYOCERA MEDICAL TECHNOLOGIES, INC.; 1200 california st; suite 210; redlands CA 92374
• Manufacturer (Section G): KYOCERA MEDICAL TECHNOLOGIES; 1200 california st; suite 210; redlands CA 92374
• Manufacturer Contact: anthony debenedictis ; 1200 california st; suite 210; redlands 92374
• MDR Report Key: 17187858
• Report Number: 3015398319-2023-00001
• Device Sequence Number: 5806982
• Product Code: MAX
• UDI-Device Identifier: 00841523134168
• UDI-Public: 00841523134168
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K212070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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 Expiration Date: 04/23/2023
• Device Model Number: S 141
• Device Catalogue Number: 1045-251-110
• Device Lot Number: 11183-14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• 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 Age: 61 YR
• Patient Sex: Male