MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SKY 2 LEVEL PLTE 30MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	186802030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Vivigen reported that a patient with degenerative disc disease and a history of bilateral knee pain, bilateral wrist pain, and lower back pain, was implanted with a 30mm skyline anterior cervical plate at levels c-5-c6, c6-c7 along with two vertigraft vg1 cervical-7 degree lordosis preservon spacers and vivigin on (b)(6) 2017.The patient was later diagnosed with basal cell carcinoma of the forehead and left forearm after an evaluation (b)(6) 2017.The date of onset of the carcinoma is reportedly (b)(6) 2017.This complaint involves devices.

• Brand Name: SKY 2 LEVEL PLTE 30MM TI
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7205237
• Report Number: 1526439-2018-50053
• Device Sequence Number: 10992151
• Product Code: KWQ
• UDI-Device Identifier: 10705034133676
• UDI-Public: 10705034133676
• Combination Product (Y/N): N
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2017

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 Catalogue Number: 186802030
• Device Lot Number: 105337
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 01/19/2018
• 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: Life Threatening; Other; Required Intervention
• Patient Age: 43 YR