CAVUX CERVICAL CAGE-B 5MM PD-31-201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2019-10-21 for CAVUX CERVICAL CAGE-B 5MM PD-31-201 manufactured by Providence Medical Technology, Inc..

MAUDE Entry Details

• Report Number: 3009394448-2019-00016
• MDR Report Key: 9216637
• Report Source: COMPANY REPRESENTATIVE,STUDY
• Date Received: 2019-10-21
• Date of Report: 2019-10-15
• Date of Event: 2019-09-23
• Date Mfgr Received: 2019-09-23
• Date Added to Maude: 2019-10-21
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DR. JANIE MANDRUSOV
• Manufacturer Street: 3875 HOPYARD RD SUITE 300
• Manufacturer City: PLEASANTON CA 94588
• Manufacturer Country: US
• Manufacturer Postal: 94588
• Manufacturer Phone: 4153013128
• Manufacturer G1: PROVIDENCE MEDICAL TECHNOLOGY, INC.
• Manufacturer Street: 3875 HOPYARD RD SUITE 300
• Manufacturer City: PLEASANTON CA 94588
• Manufacturer Country: US
• Manufacturer Postal Code: 94588
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CAVUX CERVICAL CAGE-B 5MM
• Generic Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Product Code: ODP
• Date Received: 2019-10-21
• Model Number: PD-31-201
• Catalog Number: PD-31-201
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PROVIDENCE MEDICAL TECHNOLOGY, INC.
• Manufacturer Address: 3875 HOPYARD RD SUITE 300 PLEASANTON CA 94588 US 94588

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-10-21