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

Catalog Number	6470315
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Weakness (2145); Numbness (2415); No Code Available (3191)
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) 2014, patient presented with pre-op diagnosis as disc herniation with myelopathy.For which patient underwent a standard anterior approach for cervical arthroplasty at levels c5-c6.Post-op, over time the inferior side of the implant looked to migrate anteriorly.From the films, the distance disc migrated looks about 3mm.The surgeon was not comfortable with the distance the implant had migrated and felt the implant needed to be removed.On (b)(6) 2016, after explanting the disc, a cervical fusion at c5-c6 was performed.The product came in contact with the patient.On (b)(6) 2016, patient began to have symptoms of numbness and weakness.
Additional Manufacturer Narrative
Image review: post-op revision x-rays provided for c5-6 artificial disc replacement are provided.Flexion extension shows some exaggerated motion in the spine above the implanted level.The bottom part of the device is anteriorly displaced a few millimeters at the two year point from surgery.The position osteophyte at c6 does not appear to have been drilled flush with the vertebral body.It is unclear what the initial placement of the device looked like or whether the alignment changed over time.
Additional Manufacturer Narrative
Product analysis: visual and optical examination of the implant identified ~3mm cut in the sheath, which appears to have been created by sharp object, consistent with explantation, but shells appear to be undamaged.Microscopic examination of the sintered porous coating identified boney in-growth on both sides of the shells.Dimensional inspection confirmed outside dimensions were found to be within print specification.Unable to determine root cause of implant migration from the available information.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
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRYAN CERVICAL DISC SYSTEM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6232185
• Report Number: 1030489-2017-00063
• Device Sequence Number: 11148837
• Product Code: MJO
• UDI-Device Identifier: 00613994181213
• UDI-Public: 00613994181213
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P060023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/09/2017

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 Expiration Date: 09/10/2018
• Device Catalogue Number: 6470315
• Device Lot Number: 0280357W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 03/09/2017
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 01/30/2017; 04/03/2017; 09/28/2017
• 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: 30 YR
• Patient Weight: 93