MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY, INC. CAVUX CERVICAL CAGE-B 4MM; CERVICAL INTERVERTEBRAL FUSION DEVICE

Model Number	PD-31-200
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Codes	Weakness (2145); Numbness (2415)
Date of Event	12/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event did not result in a death or a life-threatening injury.There was no device defect or malfunction reported with the devices.The patient experienced unrelieved numbness and weakness of the left arm since the initial cage implantation whose cause is uncertain.When a ct and emg scan was performed, the surgeon observed the cages were placed too medially.As a result, the surgeon performed a surgical re-intervention to remove all implanted cages from c4-c7 and, in addition, performed a laminotomy and foraminotomy.To date, the patient's symptoms still have not been resolved.For this reason, this event was reported.It is noted that this case used three different cage implant lots during procedure on the same day for the same patient.This mdr is for lot 1005037.The other two lots for this exact same case will be reported on separate mdrs.
Event or Problem Description
A patient who received posterior c4-c7 cervical intervertebral fusion on (b)(6) 2016 had to go through a re-intervention on (b)(6) 2017 to prevent the potential for permanent impairment of the left arm.The implanted cages were placed medially enough to result in the patient experiencing left arm numbness and weakness for about 6 months before the re-intervention.All implanted cervical cages from c4-c7 were removed with laminotomy and foraminotomy during procedure.But, the patient's symptoms are still not totally resolved.

• Brand Name: CAVUX CERVICAL CAGE-B 4MM
• Common Device Name: CERVICAL INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n.california blvd.; suite 320; walnut creek CA 94596
• MDR Report Key: 6790399
• Report Number: 3009394448-2017-00003
• Device Sequence Number: 139168
• Product Code: ODP
• UDI-Device Identifier: 00852776006003
• UDI-Public: 00852776006003
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 1005037
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/11/2017
• 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: 58 YR
• Patient Weight: 77