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

Model Number PD-31-202

Device Problem Malposition of Device (2616)

Patient Problem Neck Pain (2433)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Female patient underwent successful circumferential fusion on (b)(6) 2020 with interbody devices placed anteriorly and cervical cages placed posteriorly at c5-c6 and c6-c7.3 days post procedure, patient complained of shoulder and tricep pain initiating a ct scan.The ct scan confirmed one of four cervical cages placed posteriorly, at c6-c7 on the right, was malpositioned and could be contributing to nerve root irritation and pain.On (b)(6) 2020, the surgeon removed the cage and performed a foraminotomy at c6-c7 on the right.No device defect or malfunction or permanent impairment was reported by the surgeon and no issues were reported at any other treated level.The surgeon hypothesized that shallow facets and anterior distraction could have contributed to cage malposition.The patient is healing as expected with no subsequent issues.

Event Description

Female patient underwent successful circumferential fusion on (b)(6) 2020 with interbody devices placed anteriorly and cervical cages placed posteriorly at c5-c6 and c6-c7.3 days post procedure, patient complained of shoulder and tricep pain initiating a ct scan.The ct scan confirmed one of four cervical cages posteriorly, at c6-c7 on the right, was malpositioned and could be contributing to nerve root irritation and pain.On (b)(6) 2020, the surgeon removed the cage and performed a foraminotomy at c6-c7 on the right.No device defect or malfunction or permanent impairment was reported by the surgeon.The surgeon hypothesized that shallow facets and anterior distraction could have contributed to cage malposition.The patient is healing as expected with no subsequent issues.

• Brand Name: CAVUX CERVICAL CAGE-SB
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; 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 rd; suite 300; pleasanton, CA 94588 ; 4153013128
• MDR Report Key: 9635213
• MDR Text Key: 176784446
• Report Number: 3009394448-2020-00001
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/13/2021
• Device Model Number: PD-31-202
• Device Catalogue Number: PD-31-202
• Device Lot Number: 047729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: No
• 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