MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	6961460
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Neck Pain (2433)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that pre operatively patient was having pain which is going down the left shoulder, arm, hand.This occurred periodically without much warning.The mri detected stenosis at c6-7 along with bond spurs.The pain came at a time that rendered patient unable to drive, which caused an auto accident.Allegedly, the two stainless steel metal plates were installed where the bottom plate was parallel with the shoulder, but the upper plate was at an angle of 15 degrees.Post operatively, with the malposition of the cervical disc device, patient was unable to go more than 4 pt sessions due to the increase in pain.He planned to provide permission to review his x-ray, which clearly shows the malposition.It looks like one hole was drilled in the wrong position.Patient was experiencing pain in the neck area going down the right shoulder to his elbow.
Event or Problem Description
It was reported that the patient continues to have a complaint of pain.Patient suffers with continuous neck pain and intermittent neck pain radiating down the right shoulder to elbow.Pain prior to the implant was on the opposite side.Reportedly, "the front view of x-ray clearly shows a positioning difference between the top and bottom mounting plates.".

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6766240
• Report Number: 1030489-2017-01858
• Device Sequence Number: 11135582
• Product Code: MJO
• UDI-Device Identifier: 00613994129215
• UDI-Public: 00613994129215
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6961460
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 09/18/2017
• 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: Other