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

Model Number PD-31-203

Device Problem Malposition of Device (2616)

Patient Problem Muscle Weakness (1967)

Event Date 08/10/2021

Event Type  Injury  

Event Description

This event did not result in a death or life-threatening injury.There was no device malfunction reported with the devices.Index procedure was a 4 level cervical fusion, completed on (b)(6) 2021.Patient had radicular symptoms and axial neck pain due to posterior facet degeneration.Post index procedure, patient reported deltoid weakness, but no pain.Follow up ct imaging revealed 2 implants were malpositioned medially.There was no malfunction of the device.Revision procedure to remove malpositioned cage was completed as planned, both suspect implants were retrieved.

• Brand Name: CAVUX CERVICAL CAGE-X
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 4234 hacienda dr. suite 150; pleasanton CA 94588
• Manufacturer (Section G): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 4234 hacienda rd. suite 150; pleasanton CA 94588
• Manufacturer Contact: edward liou ; 4234 hacienda rd. suite 150; pleasanton, CA 94588 ; 4159239376
• MDR Report Key: 12440270
• MDR Text Key: 270342289
• Report Number: 3009394448-2021-00001
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: PD-31-203
• Device Catalogue Number: PD-31-203
• Device Lot Number: 052690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR