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

Model Number	PD-32-200
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Neck Pain (2433)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event did not result in a death or life-threatening injury.There was no device malfunction reported with the devices.Patient is ex-football player, with history of previous injuries, including broken jaw and lower back injury, resulting in a fracture at l2.Patient reported experiencing a "traumatic event" approximately 6 months post procedure, when he turned his neck abruptly, heard a "cracking noise" and experienced more severe pain.Physician noted a bicycle accident in medical records for the 2 months follow up visit, patient denies this occurred.In (b)(6) 2017, patient sought 2nd opinions from 3 additional physicians, who all noted that there were fractures and that 3 of 4 cages migrated.Patient reports that these 3 physicians recommended a revision procedure but declined to operate.Original surgeon offered a revision procedure, patient declined.The event is being reported because to date, the patient reports symptoms remain unresolved, and another surgery to address his symptoms was recommended by his surgeon.
Event or Problem Description
On (b)(6) 2019 patient contacted pmt and reported that on (b)(6) 2017, he underwent a posterior fusion procedure at c3-c4, and c4-c5 levels, with pmt cages.He also reported a possible traumatic incident post procedure as well as fractures at c2, c5 and c6, as well as and 3 cage migrations.Currently, almost two years post procedure, patient reports pain, both in the arm and neck, incontinence, arm numbness and tingling, difficulty to move his right hand and tendency to lose consciousness upon abrupt neck turning.
Event or Problem Description
This supplemental report is being submitted to provide additional information received through a voluntary report submitted directly by the patient.The voluntary report contained the patient's experience with the device.This information has been reviewed and this supplemental report is being filed to ensure the fda has the most complete and accurate record of the event.No changes to the initial conclusions regarding device involvement have been made based on this voluntary report.
Additional Manufacturer Narrative
An mdr was submitted for this report on february 13, 2019, report number 3009394448-2019-00001.This is a supplemental report based on a voluntary report submitted to the fda: mw5171222.

• Brand Name: CAVIX CERVICAL CAGE-B
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY; 3875 hopyard dr. suite 300; pleasanton CA 94588
• Manufacturer (Section G): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd. suite 300; pleasanton CA 94588
• Manufacturer Contact: janie mandrusov ; 3875 hopyard dr. suite 300; pleasanton, CA 94588 ; 4153013128
• MDR Report Key: 8338075
• Report Number: 3009394448-2019-00001
• Device Sequence Number: 19079231
• Product Code: ODP
• UDI-Device Identifier: 10852776006000
• UDI-Public: (01)10852776006000(17)190124(10)1005283
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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
• Device Expiration Date: 01/24/2019
• Device Model Number: PD-32-200
• Device Catalogue Number: PD-32-200
• Device Lot Number: 1005283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male