MAUDE Adverse Event Report: NEUROSTRUCTURES INC. 28MM TEMPUS CERVICAL PLATE SYSTEM; ANTERIOR CERVICAL PLATE SYSTEM

Model Number 10-02-028

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

Physician reported that they had trouble locking the plate and believe that the screw backed out by a few turns.Device remains implanted as revision surgery is not required.

• Brand Name: 28MM TEMPUS CERVICAL PLATE SYSTEM
• Type of Device: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): NEUROSTRUCTURES INC.; irvine CA
• Manufacturer Contact: moti altarac ; 16 technology dr ste 165; irvine, CA 92618 ; 8003526103
• MDR Report Key: 4788964
• MDR Text Key: 5883184
• Report Number: 3008853203-2015-00026
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-02-028
• Device Catalogue Number: 10-02-028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1