MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY CAVUX CERVICAL CAGE-X, 4MM; Intervertebral fusion device with bone graft, cervical

Model Number PD-31-203

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/16/2023

Event Type  Injury  

Event Description

On november 16, 2023 pmt was notified of a revision involving providence medical technology (pmt) devices.The revision procedure was on (b)(6) 2023.It is not known when the index procedure was performed.The index procedure involved an anterior and posterior fusion.Roi-c was implanted at c3-4, c4-5, c5-6, c6-7.In addition to the standalone roi-c intervertebral body cage, the patient received a 4 level maxan anterior plate and screws.Pmt products cage-x 4mm and bone screws were implanted posteriorly at c3-4, c4-5, c5-6, c6-7.A few weeks later the patient went back to the doctor and it was discovered that the middle portion of the anterior construct pulled forward taking out the middle roi-c cage and the middle screws of the max anterior plate.The doctor mentioned that the patient had poor bone density.It is also believed that because of the patient's comorbidities and in conjunction with the other devices may have caused the patient to go into kyphosis forcing the anterior construct forward and the posterior devices to migrate.There was no breakage of the pmt devices noted.The patient went through a revision surgery where the anterior construct was removed and replaced along with the posterior construct being replaced by lateral mass screws and rods.It was confirmed on (b)(6) 2023 that the patient is recovering well from the revision surgery.

• Brand Name: CAVUX CERVICAL CAGE-X, 4MM
• Type of Device: Intervertebral fusion device with bone graft, cervical
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY; 4234 hacienda drive; suite 150; pleasanton CA 94588
• Manufacturer (Section G): PROVIDENCE MEDICAL TECHNOLOGY, INC; 4234 hacienda drive; suite 150; pleasonton CA 94588
• Manufacturer Contact: edward liou ; 4234 hacienda drive; pleasanton, CA 94588 ; 4155213412
• MDR Report Key: 18323315
• MDR Text Key: 330428882
• Report Number: 3009394448-2023-00012
• 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
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PD-31-203
• Device Catalogue Number: PD-31-203
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male