MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY, INC. CAVUX CERVICAL CAGE-B 5MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number PD-31-201

Device Problem Malposition of Device (2616)

Patient Problem Neck Pain (2433)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

This event did not result in a death or life-threatening injury.There was no device defect or malfunction reported by the surgeon.Patient underwent successful cervical fusion procedure with cervical cages placed posteriorly bilaterally at c3-c6.Two weeks post-procedure, the patient presented with right-side radicular pain.Ct scan confirmed cage malposition.Only one of six cages was removed four weeks post-index procedure and was not replaced.Surgeon reported revision surgery went well and patient is doing well as of the time of this report.

Event Description

Patient underwent successful cervical fusion on (b)(6) 2019 with cervical cages placed posteriorly bilaterally from c3-c6.Patient presented two weeks post-procedure with right-side radicular pain.Ct scan confirmed malposition of cage on the right at c5-c6.Only one of six implanted cages was removed on (b)(6) 2019, 1 month post-index procedure.Patient is doing well.Surgeon did not report any device defect or malfunction.

• Brand Name: CAVUX CERVICAL CAGE-B 5MM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; suite 300; pleasanton CA 94588
• Manufacturer (Section G): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; suite 300; pleasanton CA 94588
• Manufacturer Contact: janie mandrusov ; 3875 hopyard rd; suite 300; pleasanton, CA 94588 ; 4153013128
• MDR Report Key: 9216637
• MDR Text Key: 163088737
• Report Number: 3009394448-2019-00016
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PD-31-201
• Device Catalogue Number: PD-31-201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention