MAUDE Adverse Event Report: NEUROSTRUCTURES, INC TEMPUS CERVICAL PLATE SYSTEM

Catalog Number	10-03-048
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts were returned for evaluation.
Event or Problem Description
Revision of case done on (b)(6) 2016 due to broken plate locking mechanism and screw back out.

• Brand Name: TEMPUS CERVICAL PLATE SYSTEM
• Common Device Name: TEMPUS
• Manufacturer (Section D): NEUROSTRUCTURES, INC; 16 technology drive; irvine CA 92618
• MDR Report Key: 6537194
• Report Number: 3008853203-2017-00003
• Device Sequence Number: 16294157
• Product Code: KWQ
• UDI-Device Identifier: 00841508100218
• UDI-Public: 00841508100218
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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 Catalogue Number: 10-03-048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1