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

Model Number PD-31-203

Device Problem Malposition of Device (2616)

Patient Problem Neck Pain (2433)

Event Date 08/16/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020 a patient received a single level posterior cervical fusion with cervical cages placed posteriorly at c6-c7.The patient had a previous 3-level acdf and a previous c7-t1 posterior cervical fusion.No abnormal anatomy was noted in the index procedure other than the previous fusion at c7-t1 requiring a need to approach the target level at a slightly higher angle relative to the facet joint angle.The patient returned one day later complaining of right arm pain, initiating imaging.In a post-operative ct, the surgeon suspected the cervical cages were malpositioned.The cervical cage on the right side was removed and replaced with another cervical cage.The cervical cage on the left side was malpositioned and repositioned.Patient is recovering well with no arm pain or clinical sequelae.No device defect or malfunction was reported.

Event Description

On (b)(6) 2020 a patient received a single level posterior cervical fusion with cervical cages placed posteriorly at c6-c7.The patient had a previous 3-level acdf and a previous c7-t1 posterior cervical fusion.The patient returned one day later complaining of right arm pain, initiating imaging.In a post-operative ct, the surgeon suspected the cervical cages were malpositioned.The cervical cage on the right side was removed and replaced with another providence medical technology cervical cage.Also, the cervical cage on the left side was also malpositioned and repositioned.Patient is recovering well with no arm pain.No device defect or malfunction was reported.

• Brand Name: CAVUX CERVICAL CAGE-X
• 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: 10469090
• MDR Text Key: 204985029
• Report Number: 3009394448-2020-00006
• 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: 08/20/2020

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: 06/03/2022
• Device Model Number: PD-31-203
• Device Catalogue Number: PD-31-203
• Device Lot Number: 050138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2020
• 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: 53 YR