MAUDE Adverse Event Report: KYOCERA MEDICAL TECHNOLOGIES, INC. KYOCERA MEDICAL TECHNOLOGIES, INC.; SA CERVICAL SCREW 4.0MM SELF TAPPING, 12MM

Model Number	S 150
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, an expired cervical screw was inadvertently implanted into the patient and immediately taken out.There was no reported patient injury/infection.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.Review of manufacturing records confirms product was manufactured to specification and there is no indication of a product quality issue with respect to design, manufacturing, or labeling.To date, this is the only reported complaint from this manufacturing lot released for distribution in (b)(6) 2016.Should additional information be provided, a supplemental mdr will be submitted.Expired implant was discarded and not returned.
Event or Problem Description
An expired screw was used during procedure.Screw expired (b)(6) 2021.Screw was immediately taken out and replaced with an unexpired screw.Note: no revision surgery occurred.

• Brand Name: KYOCERA MEDICAL TECHNOLOGIES, INC.
• Common Device Name: SA CERVICAL SCREW 4.0MM SELF TAPPING, 12MM
• Manufacturer (Section D): KYOCERA MEDICAL TECHNOLOGIES, INC.; 1200 california st.; suite 210; redlands CA 92374
• Manufacturer (Section G): KYOCERA MEDICAL TECHNOLOGIES, INC.; 1200 california st.; suite 210; redlands CA 92374
• Manufacturer Contact: anthony debenedictis ; 1200 california st.; suite 210; redlands, CA 92374 ; 9095572160
• MDR Report Key: 13006482
• Report Number: 3015398319-2021-00003
• Device Sequence Number: 20042632
• Product Code: ODP
• UDI-Device Identifier: 00841523118045
• UDI-Public: 00841523118045
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153250
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

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: Health Professional
• Device Expiration Date: 08/26/2021
• Device Model Number: S 150
• Device Catalogue Number: 1050-240-012
• Device Lot Number: 3683-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2016
• 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