MAUDE Adverse Event Report: MEDTRONIC VERTE-STACK ANATOMIC; SPINAL VERTEBRAL BODY

Model Number	6240841
Health Effect - Clinical Codes	Dysphasia (2195); Numbness (2415); Choking (2464); No Code Available (3191)
Date of Event	08/02/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2011, dr.(b)(6) performed a two-level anterior cervical discectomy at c4-c5, c5-c6 with verte-stack anatomic end-caps, the endcap size is 14 x 11mm footprint by 8mm height lordotic.Device labeling states it is contraindicated for the cervical spine, the surgeon did not disclose that the device was not approved for use in the neck nor did the surgeon disclose that the device has not been shown to be safe and effective.I developed post-op complications including but not limited to dysphagia, dysphonia, choking, difficulty swallowing and loss of feeling in the hands, fingers, and arms i will be undergoing revision surgery shortly.The device labeling directs the doctor to implant the device into thoracic/lumbar spine, but the size and shape of the device only fits into the cervical spine.The exp date is mar 2010.Dr.(b)(6) never disclosed that he was going to use an expired and mislabeled product at the (b)(6) medical center.

• Brand Name: VERTE-STACK ANATOMIC
• Common Device Name: SPINAL VERTEBRAL BODY
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6845585
• Report Number: MW5071985
• Device Sequence Number: 16521841
• Product Code: MQP
• UDI-Device Identifier: 00613994305091
• UDI-Public: 00613994305091
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/02/2017

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: 03/21/2010
• Device Model Number: 6240841
• Device Lot Number: T232
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 75