MAUDE Adverse Event Report: MEDTRONIC INC. MEDTRONIC VERTEX MAX FROM C5-T1; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

The complaint received states that a patient who received a prodisc-c has experienced continuous pain and limited range of motion with malposition of the device.It was reported by the patient that she underwent a trauma fusion procedure from c5-t1 with a competitor's product on (b)(6) 2011.She visited a different surgeon on an unknown date and he advised her that by implanting a prodisc-c at the adjacent level would help her alignment.On (b)(6) 2011, the patient underwent a removal procedure of all of the hardware from c5-t1.The patient was then flipped over and underwent an implant of prodisc-c at c4-5.Since the procedure, the patient has visited other doctors on unknown dates for x? rays and they have told her there is a malposition of the device.The patient is in continuous pain.She states the device is tilted down and pointing forward.She cannot flex and has kyphosis from the position of the device.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MEDTRONIC VERTEX MAX FROM C5-T1
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 17530207
• MDR Text Key: 321081656
• Report Number: MW5137127
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1