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

Model Number	PD-31-200
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was discovered during discussions with a surgeon who did not perform surgery on the patient.Attempts were made to contact the original surgeon via phone and email with no response received.Patient underwent posterior fusion on (b)(6) 2018 with cervical cages placed posteriorly at c6-c7 and c7-t1.However, c5-c6 and c6-c7 were intended treatment levels.Post procedure, patient complained of right arm pain initiating a ct scan.The ct scan confirmed two of four cervical cages placed posteriorly, at c6-c7 and c7-t1 on the right, were malpositioned and could be contributing to neuritis.On (b)(6) 2018, the surgeon removed one cage at c7-t1 on the right.The cervical cage at c6-c7 was found to be placed deeper than an ideal position and could contribute to right arm pain but the cervical cage at this level was not removed.Patient received an acdf at c6-c7 from another surgeon in 2019.The cervical cage at c6-c7 was not touched at this time.No device defect or malfunction or permanent impairment was reported by either surgeon.The surgeons were not able to be reached for an update on the patient but no other clinical sequelae have been documented.
Event or Problem Description
Patient underwent posterior fusion on (b)(6) 2018 with cervical cages placed posteriorly at c6-c7 and c7-t1.However, c5-c6 and c6-c7 were intended treatment levels.Post procedure, patient complained of right arm pain initiating a ct scan.The ct scan confirmed two of four cervical cages placed posteriorly, at c6-c7 and c7-t1 on the right, were malpositioned and could be contributing to neuritis.On (b)(6) 2018, the surgeon removed one cage at c7-t1 on the right.The cervical cage at c6-c7 was found to be placed deeper than an ideal position and could contribute to right arm pain but the cervical cage at this level was not removed.Patient received an acdf at c6-c7 from another surgeon in 2019.The cervical cage at c6-c7 was not touched at this time.No device defect or malfunction or permanent impairment was reported by either surgeon.The surgeons were not able to be reached for an update on the patient but no other clinical sequelae have been documented.

• Brand Name: CAVUX CERVICAL CAGE-B
• 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: 9908595
• Report Number: 3009394448-2020-00002
• Device Sequence Number: 11466682
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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: 06/27/2020
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 046116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/31/2020
• 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