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 Codes	Muscle Weakness/Atrophy (1967); Neck Pain (2433)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 10469030
• Report Number: 3009394448-2020-00007
• Device Sequence Number: 14233083
• 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): 08/27/2020

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/28/2020
• 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: 75 YR