MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	876-614
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neuropathy (1983); Numbness (2415); Neck Pain (2433)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it is unknown if the devices led to the event, we are filing this report for notification purposes.Following devices were involved in the event: part# unknown plate; qty:1 part# 876-614; qty:6 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
Procedure used: extra pharyngeal anterolateral levels implanted: c5-6, c6-7 it was reported that on (b)(6) 2013, patient was diagnosed with high-grade stenosis at c4-5 and underwent anterior cervical discectomy and fusion (c4-5) and allograft, plate fixation, and removal of old plate (c5-7).Patient tolerated the procedure well with no complications.Approximately 54 months postoperatively, the patient complained of neck pain and stiffness, decreased range of motion, and occasional radiation into shoulders.Treatment included a cervical mri on (b)(6) 2011 that showed c4-c5 degenerative disc disease and disc protrusion.The patient considered the neck pain tolerable at this point, so the site reported they would continue to observe.Approximately 86 months postoperatively, the patient complained of pain in his neck with radiation to shoulders and arms, left greater than right with numbness in the left upper extremity.No treatment was provided.Approximately 88 months postoperatively, the patient had progression of neck pain and upper extremity pain that resulted in surgery.At the 120-months postoperative evaluation, the patient had residual neck pain that is a permanent condition.

• Brand Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 6970943
• Report Number: 1030489-2017-02232
• Device Sequence Number: 444127
• Product Code: KWP
• UDI-Device Identifier: 00721902175572
• UDI-Public: 00721902175572
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K970806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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: 876-614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/24/2017
• 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
• Patient Age: 45 YR
• Patient Weight: 95