MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CERVICAL DISC BRYAN; PROSTHESIS, INTEVERTEBRAL DISC

Model Number 6470114

Device Problem Break (1069)

Patient Problems Pain (1994); Weakness (2145)

Event Date 08/15/2013

Event Type  Injury  

Event Description

I was operated on a cervical hernia, i had bryan cervical prosthesis implanted in my cervical spine c5-c6, i did not recover and the symptoms worsened as the years went by until 2013, i was able to perform an mri magnetic resonance and saw that the cervical disc bryan was displaced touching the nerve and the nerve roots of the c6.Now it need to be removed because it is putting me at risk of paralysis or death.Medtronic sofamor danek did not want to verify the device number and model to include me in its adverse programs.It was when we found out about the serious damage in 2015 that they performed another rm i and the disc was pressing more on my spinal cord.I am currently having a lot of pain and weakness and muscle strength throughout my body.In (b)(6) there is no specialized team in cervical spine and clinic specialized in neuropathic pain.Our neurosurgeon tells us that only in usa or germany can they do the operation because in (b)(6) they did not have the capacity.The implant is broken because the polyurethane is touching the spinal cord and both nerve roots of the c6.

• Brand Name: CERVICAL DISC BRYAN
• Type of Device: PROSTHESIS, INTEVERTEBRAL DISC
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC. ; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7846509
• MDR Text Key: 119489008
• Report Number: MW5079568
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: CS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6470114
• Device Catalogue Number: 6470114
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 49