MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY CAVUX CERVICAL CAGE-B

Model Number PD-31-200

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Event Description

A patient was treated at c6- c7 level in a case that involved providence products.The patient later experienced c7 radicular symptoms.The surgery was revised.Revision surgery resolved symptoms.No product malfunctions were reported.The physician noted that the cages may have been malpositioned and caused the suspected issue.The physician declined to provide additional information.

• Brand Name: CAVUX CERVICAL CAGE-B
• Type of Device: CERVICAL CAGE
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY; 3875 hopyard dr. suite 300; pleasanton CA 94588
• Manufacturer (Section G): PROVIDENCE MEDICAL TECHNOLOGY; 3875 hopyard dr. suite 300; pleasanton CA 94588
• Manufacturer Contact: janie mandrusov ; 3875 hopyard dr. suite 300; pleasanton, CA 94588 ; 4153013128
• MDR Report Key: 8049332
• MDR Text Key: 126505925
• Report Number: 3009394448-2018-00002
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention