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	Neuropathy (1983); Weakness (2145); Tingling (2171); Stenosis (2263); Numbness (2415)
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 surgery.Post-op, patient suffered with radiculopathy and surgeon suspects continued cervical stenosis.Following initial implant, symptoms of right arm pain, numbness, tingling and weakness persisted.The product came in contact with the patient.The product didn't break.On (b)(6) 2016, patient underwent revision surgery at levels c5/6 with primary diagnosis for revision surgery as c5/6 radiculopathy.
Additional Manufacturer Narrative
Image review: post-op x-rays and mri provided for c5-6 prestige lp disc replacement shows graft improperly positioned on x-ray in the interbody space.Mri shows extensive artifact but probably some central canal stenosis.The right c5-6 neural foramen is not seen.Suspect incomplete decompression of disc space and foramen with inadequate preparation of end plate anatomy for device placement.
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.
Additional Manufacturer Narrative
Product analysis: device meets specifications.No defects observed during visual analysis or through dimensional and functional checks.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: 6101351
• Report Number: 1030489-2016-03142
• Device Sequence Number: 19080103
• Product Code: MJO
• UDI-Device Identifier: 00613994493705
• UDI-Public: 00613994493705
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/19/2017

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: 10/16/2022
• Device Catalogue Number: 6972460
• Device Lot Number: 0335300W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Initial Date Received by Manufacturer: 10/20/2016
• Supplement Date Received by Manufacturer: Not provided; 07/19/2017; 07/19/2017
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 12/02/2016; 08/16/2017; 09/26/2017
• 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: 32 YR
• Patient Weight: 68