MAUDE Adverse Event Report: NEUROSTRUCTURES,INC TEMPUS ANTERIOR CERVICAL PLATE; TEMPUS, PRODUCT CODE: KWQ

Catalog Number	10-01-012
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Patient received a acdf on 5/3/17.No known issues at the time.The surgery was successful.Patient returned with a screw protruding from the tempus cervical plate.The locking ring broke for the affected screw and needed a revision surgery.

• Brand Name: TEMPUS ANTERIOR CERVICAL PLATE
• Common Device Name: TEMPUS, PRODUCT CODE: KWQ
• Manufacturer (Section D): NEUROSTRUCTURES,INC; 16 technology drive; irvine CA 92618
• MDR Report Key: 6674294
• Report Number: 3008853203-2017-00005
• Device Sequence Number: 16548079
• Product Code: KWQ
• UDI-Device Identifier: 00841508100003
• UDI-Public: 00841508100003
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K131374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2017
• Report Date (Section F): 06/15/2017

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: 10-01-012
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR