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

Model Number PD-31-200

Device Problem Malposition of Device (2616)

Patient Problem Neck Pain (2433)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020, a male patient underwent a circumferential cervical fusion with cervical cages placed posteriorly, unilaterally, on the left at c4-c5 and c5-c6.Three and a half months later on (b)(6) 2020, the patient returned complaining of pain.Imaging confirmed cages were proud posteriorly which potentially contributed to the post-operative pain.Both cervical cages placed posteriorly were removed on (b)(6) 2020.No device defect or malfunction was reported.Patient is recovering well with improved symptoms.

Event Description

On (b)(6) 2020, a male patient underwent a circumferential cervical fusion with cervical cages placed posteriorly, unilaterally, on the left at c4-c5 and c5-c6.Three and a half months later on (b)(6) 2020, the patient returned complaining of pain.Imaging confirmed cages were proud posteriorly which potentially contributed to the post-operative pain.Both cervical cages placed posteriorly were removed on (b)(6) 2020.No device defect or malfunction was reported.Patient is recovering well with improved symptoms.

• Brand Name: CAVUX CERVICAL CAGE-B
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; suite 300; pleasanton, ca
• Manufacturer (Section G): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; suite 300; pleasanton, ca
• Manufacturer Contact: ed liou ; 3875 hopyard rd; suite 300; pleasanton, ca ; 3013128
• MDR Report Key: 10388802
• MDR Text Key: 209585852
• Report Number: 3009394448-2020-00005
• Device Sequence Number: 1
• Product Code: ODP
• UDI-Device Identifier: 00852776006423
• UDI-Public: 00852776006423
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/16/2021
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 048777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• 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: 60 YR