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

Catalog Number	6972670
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neck Pain (2433); 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) 2015, patient underwent standard one level cervical disc arthroplasty at level c4-5, due to pre-op diagnosis as neck pain where patient was implanted with an artificial cervical disc at c4/c5.Reportedly, post-op, patient continued to have neck pain.Surgeon explained that this was a workman's comp case and the implant was positioned properly and did not appear to have failed in any way.The removal of the implant and fusion of this level was planned as a result of this event.On (b)(6) 2017, the artificial cervical disc was removed at c4/c5.Removal of the disc was uncomplicated.
Additional Manufacturer Narrative
Image review: submitted images appear to show surface abrasion on ball component of implant.Product analysis: device meets specifications.No defects observed during visual analysis or through dimensional and functional checks.

• 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: 6325132
• Report Number: 1030489-2017-00297
• Device Sequence Number: 694331
• Product Code: MJO
• UDI-Device Identifier: 00613994493651
• UDI-Public: 00613994493651
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/13/2017

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: 10/30/2022
• Device Catalogue Number: 6972670
• Device Lot Number: 0335294W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: 07/13/2017; 07/13/2017
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 08/08/2017; 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 Weight: 68