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

Catalog Number	6972660
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Chest Pain (1776); Tingling (2171); Numbness (2415); Neck Pain (2433)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
Event or Problem Description
It was reported that on (b)(6) 2015 (month and year valid), patient underwent surgery.Reportedly, post-op, patient suffered with neck pain, pain in the shoulder that extended across chest.Patient also complained of numbness and tingling in fingers.For which, on (b)(6) 2016, patient underwent fusion revision surgery at levels c5/c6.The surgeon felt that there was forward translation of superior device component based on flexion/extension x-rays.Upon performing anterior cervical approach from the right side, the surgeon noted that the device was implanted off midline to the left, angled toward him.No patient complications were reported in the revision surgery.
Additional Manufacturer Narrative
Image review: c5-6 artificial disc replacement post-op x-rays show a deformity at the implanted level.On "ap" views, the device has been placed slightly to the left of midline.Because of surgery complaints of neck pain and prosthesis, a revision surgery was performed by report.Root cause: surgical technique.
Event or Problem Description
Pre-op diagnosis: spinal instability at c5-6 secondary to an artificial disc or arthroplasty failure.Post initial surgery dynamic x-ray showed subluxation with the c5 body on c6 and interspinous space between c5 and c6 was incredibly wide.Mri showed some angulation of the body of c5 and so the canal was compromised in several positions.Tissue was not collected as written informed consent was not obtained.Following initial surgery, pain symptoms of patient were resolved.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 6217752
• Report Number: 1030489-2017-00014
• Device Sequence Number: 464673
• Product Code: MJO
• UDI-Device Identifier: 00613994493668
• UDI-Public: 00613994493668
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/24/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6972660
• Device Lot Number: 037210W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided; 01/24/2017; 01/24/2017
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 01/30/2017; 09/28/2017; 09/29/2017
• 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: 47 YR