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

Model Number	PD-31-203
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	08/16/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 10469090
• Report Number: 3009394448-2020-00006
• Device Sequence Number: 3120196
• 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): 08/20/2020

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: 06/03/2022
• Device Model Number: PD-31-203
• Device Catalogue Number: PD-31-203
• Device Lot Number: 050138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2020
• 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: 53 YR