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

Catalog Number 186802030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cancer (3262)

Event Date 01/01/2017

Event Type  Injury  

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 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
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SARL; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7205237
• MDR Text Key: 97721631
• Report Number: 1526439-2018-50053
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10705034133676
• UDI-Public: 10705034133676
• Combination Product (y/n): N
• PMA/PMN Number: K052552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 186802030
• Device Lot Number: 105337
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2017
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 43 YR