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

Model Number	PD-31-200
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Female patient with history of previous cervical spinal fusion surgery underwent 1 level posterior cervical fusion with cervical cages placed posteriorly at c7-t1 and partial foraminotomy (on right side) on (b)(6) 2019.Patient continued to complain of pain and pseudarthrosis was noted at c7-t1 likely due to the development of excessive scar tissue (according to the surgeon).On (b)(6) 2020, cervical cages placed posteriorly bilaterally at c7-t1 were removed and replaced.Both surgeries went as expected with no reported device defect or malfunctions.Patient is recovering well.Cavux cervical cage-b is not indicated for use at c7-t1.
Event or Problem Description
Female patient with history of previous cervical spinal fusion surgery underwent 1 level posterior cervical fusion with cervical cages placed posteriorly at c7-t1 and partial foraminotomy (on right side) on (b)(6) 2019.Patient continued to complain of pain and pseudarthrosis was noted at c7-t1 likely due to the development of excessive scar tissue (according to the surgeon).On (b)(6) 2020, cervical cages placed posteriorly bilaterally at c7-t1 were removed and replaced.Both surgeries went as expected with no reported device defect or malfunctions.Patient is recovering well.Cavux cervical cage-b is not indicated for use at c7-t1.

• Brand Name: CAVUX CERVICAL CAGE-B
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; suite 300; pleasanton, ca
• MDR Report Key: 9931631
• Report Number: 3009394448-2020-00003
• Device Sequence Number: 11700475
• Product Code: ODP
• UDI-Device Identifier: 00852776006423
• UDI-Public: 00852776006423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 08/08/2021
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 048545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention