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

Catalog Number	6972660
Medical Device Problem Code	Metal Shedding Debris (1804)
Health Effect - Clinical Codes	Neck Pain (2433); No Code Available (3191)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image review: post op x-rays were provided for c5-6 anterior cervical diskectomy and fusion (acdf), c6-7 artifical disc replacement.The initial indications for performing the procedure are unknown.A revision surgery was performed for "chronic neck pain".No construct failure is evident on images provided.No hardware malpositioning or reported complication with the medtronic device has seemingly occured.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.
Event or Problem Description
It was reported that on (b)(6) 2015, the patient underwent a surgery, in which the artificial disc was implanted at levels c6-c7.On an unknown date, post-op, allegedly, the patient experienced chronic neck pain.The surgeon suspected lack of bony in growth as reason for patient pain.On (b)(6) 2017, the patient underwent revision surgery, in which the artificial disc was explanted from level c6/7 with osteotome and kocher.At explant, the surgeon required "no effort" to dislodge the implant from the site.The surgeon reported that the implant was well aligned with good placement.Explant of adjacent anterior cervical diskectomy and fusion (acdf) plate screws was performed first with artificial disc removal to follow.The surgeon also removed some osteophytes from around the plate prior to exploring artificial disc.The surgeon observed metallosis in the disc space after removal.The artificial disc was replaced with a product, manufactured by another manufacturer.The patient also underwent anterior cervical diskectomy and fusion (acdf) surgery with iliac crest bone graft at c6/7.
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: 6286524
• Report Number: 1030489-2017-00152
• Device Sequence Number: 33563
• Product Code: MJO
• UDI-Device Identifier: 00613994493668
• UDI-Public: 00613994493668
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2017

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 Expiration Date: 03/26/2023
• Device Catalogue Number: 6972660
• Device Lot Number: 0372574W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: 01/03/2017
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 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: 43 YR
• Patient Weight: 73