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

Catalog Number	6972460
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Patient demographics: height- 5'9"; race- caucasian.Pre-op diagnosis for initial surgery: spondylosis with foraminal stenosis (arm and neck pain) initial surgery: index surgery level implanted: c6/c7 reason for revision surgery: dislocation of periprosthetic tissue at c6/c7 revision surgery: acdf (anterior cervical discectomy and fusion) at c6/c7 it was reported that on an unknown date, post-op, patient symptoms of neck and arm pain did not resolve following the index surgery.Hence, a revision surgery was performed to revise the implant with acdf.
Additional Manufacturer Narrative
Additional info.
Event or Problem Description
It was reported that, based on lateral intra-operative fluoroscopy, the disc appeared to be upside down with ball component placed inferior.
Additional Manufacturer Narrative
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: 6546886
• Report Number: 1030489-2017-01112
• Device Sequence Number: 81827
• Product Code: MJO
• UDI-Device Identifier: 00613994493705
• UDI-Public: 00613994493705
• 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: 2016
• 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): 05/10/2017

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: 03/19/2023
• Device Catalogue Number: 6972460
• Device Lot Number: 0367858W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided; 05/10/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 05/23/2017; 10/03/2017
• 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: Other; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 69