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 Problems Muscle Weakness (1967); Neck Pain (2433)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020, a patient underwent a 2-level circumferential cervical fusion with cervical cages placed posteriorly bilaterally.The same day, the patient complained of right-sided deltoid weakness, initiating a ct scan.The cage at c4-c5 on the right was noted to be potentially malpositioned, which could have contributed to the deltoid weakness.The same day (evening), the patient underwent a revision procedure to the or to remove the cervical cage at c4-c5 on the right during which time the surgeon performed a foraminotomy and placed lateral mass screws.No device defect or malfunction was reported.The patient is recovering with no clinical sequelae.

Event Description

On (b)(6) 2020, a patient underwent a 2-level circumferential cervical fusion with cervical cages placed posteriorly bilaterally.The same day, the patient complained of right-sided deltoid weakness, initiating a ct scan.The cage at c4-c5 on the right was noted to be potentially malpositioned, which could have contributed to the deltoid weakness.The same day (evening), the patient underwent a revision procedure to the or to remove the cervical cage at c4-c5 on the right during which time the surgeon performed a foraminotomy and placed lateral mass screws.No device defect or malfunction was reported.The patient is recovering with no clinical sequelae.

• 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
• Manufacturer (Section G): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd; suite 300; pleasanton, ca
• Manufacturer Contact: ed liou ; 3875 hopyard rd; suite 300; pleasanton, ca ; 3013128
• MDR Report Key: 10469030
• MDR Text Key: 204876398
• Report Number: 3009394448-2020-00007
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/18/2021
• Device Model Number: PD-31-202
• Device Catalogue Number: PD-31-202
• Device Lot Number: 049144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 75 YR