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

Model Number	PD-31-202
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; suite 300; pleasanton CA 94588
• MDR Report Key: 9635213
• Report Number: 3009394448-2020-00001
• Device Sequence Number: 18927468
• Product Code: ODP
• UDI-Device Identifier: 00852776006423
• UDI-Public: 00852776006423
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/21/2020

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/27/2020
• 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