MAUDE Adverse Event Report: NEUROSTRUCTURES, INC. TEMPUS; CERVICAL PLATING SYSTEM

Model Number	10-02-026
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Locking mechanism was broken.Screw was protruding out of the plate and bone.Patient came in for unrelated pain and event was discovered through an x-ray.X-ray is not available.Revision surgery was done today and all broken fragments were retrieved.No surgical delay.No adverse consequences.

• Brand Name: TEMPUS
• Common Device Name: CERVICAL PLATING SYSTEM
• Manufacturer (Section D): NEUROSTRUCTURES, INC.; 199 technology drive; suite 110; irvine CA 92618
• MDR Report Key: 7359004
• Report Number: 3008853203-2018-00015
• Device Sequence Number: 16384462
• Product Code: KWQ
• UDI-Device Identifier: 00841508100096
• UDI-Public: 00841508100096
• Combination Product (Y/N): N
• PMA/510(K) Number: K131374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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 Model Number: 10-02-026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR