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	Malposition of Device (2616)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A (b)(6)-year-old male underwent posterior cervical fusion surgery on (b)(6) 2020 with cervical cages placed bilaterally posteriorly at c4-c5, c5-c6, c6-c7.Patient is a smoker and has history of previous cervical spinal surgery; procedure was to address pseudarthrosis from previous surgery.All six cervical cages were implanted successfully but a note was made about difficulty to access facet joint due to patient anatomy and previous surgery.Approximately 3 weeks later, patient complained of right side pain prompting imaging to be taken.Imaging suggested cervical cages placed on the right side may be mal-positioned, potentially causing patient pain.A revision surgery was performed (b)(6) 2020 to remove all three cervical cages placed on the right side (c4-c7) and replace with lateral mass instrumentation.No device defect or malfunction was reported.Patient is recovering as expected.
Event or Problem Description
A (b)(6)-year-old male underwent posterior cervical fusion surgery on (b)(6) 2020 with cervical cages placed bilaterally posteriorly at c4-c5, c5-c6, c6-c7.Patient is a smoker and has history of previous cervical spinal surgery; procedure was to address pseudarthrosis from previous surgery.All six cervical cages were implanted successfully but a note was made about difficulty to access facet joint due to patient anatomy and previous surgery.Approximately 3 weeks later, patient complained of right side pain prompting imaging to be taken.Imaging suggested cervical cages placed on the right side may be mal-positioned, potentially causing patient pain.A revision surgery was performed on (b)(6) 2020 to remove all three cervical cages placed on the right side (c4-c7) and replace with lateral mass instrumentation.No device defect or malfunction was reported.Patient is recovering as expected.

• 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: 10048252
• Report Number: 3009394448-2020-00004
• Device Sequence Number: 3357714
• 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: 2020
• 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): 05/11/2020

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: 09/12/2021
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 048768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/12/2020
• 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
• Patient Age: 53 YR