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

Catalog Number	6961460
Medical Device Problem Code	Metal Shedding Debris (1804)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/15/2017
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) 2008 (year valid), patient underwent anterior cervical disc arthroplasty at levels c5-6.On (b)(6) 2017, patient presented with pre-op diagnosis as: failed arthroplasty c5-6 and adjacent degenerative disc disease c6-7.For which patient underwent revision surgery.Surgeon noticed wear debris around device upon explanting.There was wear debris (black tissue) at the site.The surgeon labeled it as failed arthroplasty because there was no movement in that segment on x-ray and bone can be seen behind the artificial cervical disc in the disc space.Per reps's personal observation, the disc was not properly sized when implanted.Per image (not available for return), rep found that the ball and trough was in the middle of the disc space with 3-4 mm of room behind it, not in the posterior part of space as it should be and this might have contributed to the auto fusion and hence the disc not working as it should.
Additional Manufacturer Narrative
Product analysis: microscopic examination of implant identified slightly off center wear in the ball and trough contact area, consistent with slightly off-centered component implantation.Minimal wear noted outside on the lower (trough) component flange, or on the outer perimeter flange edge on the upper (ball) component, consistent with parallel implantation of the components.Microscopic examination of the complaint return implant¿s wear pattern is consistent with completed life test comparison samples, suggesting the range of movement generated post operatively in vivo to be within the normal range.Microscopic examination of the wear of each component found to be significantly less pronounced in comparison with completed life test samples, suggesting the wear (or debris) generated post operatively in vivo to be within the normal range.The above observations appear to suggest the implant appears to be capable of performing its intended function.
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: 6629095
• Report Number: 1030489-2017-01506
• Device Sequence Number: 849429
• Product Code: MJO
• UDI-Device Identifier: 00613994129215
• UDI-Public: 00613994129215
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P060018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2017

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: 08/14/2012
• Device Catalogue Number: 6961460
• Device Lot Number: W07H0986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 07/27/2017; 07/27/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 08/17/2017; 10/04/2017
• 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