MAUDE Adverse Event Report: MEDTRONIC PLC VITOSS BA; BIOACTIVE BONE GRAFT SUBSTITUTE

Catalog Number 2102-1500

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Numbness (2415); Disc Impingement (2655)

Event Date 10/30/2008

Event Type  Injury  

Event Description

My hands have not operated (numbness properly since surgery.The left side hurt and well as the right side.Trouble swallowing.Breathing while asleep.It was discovered that i had several bulging disc in my neck.The 1st surgery did not heal properly.I was redone the 2nd time from the back of my head down my neck.Immediately after the 2nd surgery.My life was forever changed.I never had an accident nor fell.Since these surgeries my left has changed 180 degrees.Through debilitating pain i do some thing everyday to make my life better.I do something everyday to make my life better.I began these surgeries at (b)(6) lbs and have lost over 100 pounds through life changes and hoping for improvement.But no matter how much weight i lose the chronic pain still exist and even gets worse after i exercise but if i didn't.I was told that i would possibly be immobile and that's not going to happen! both surgeries were done.At (b)(6).Approx 1 week after the second surgery, the entire practice was dismantled and i haven't seen dr.(b)(6) since but i did find him on (b)(6).

• Brand Name: VITOSS BA
• Type of Device: BIOACTIVE BONE GRAFT SUBSTITUTE
• Manufacturer (Section D): MEDTRONIC PLC
• MDR Report Key: 5888350
• MDR Text Key: 52725078
• Report Number: MW5064182
• Device Sequence Number: 3
• Product Code: MQV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/26/2016
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2010
• Device Catalogue Number: 2102-1500
• Device Lot Number: 0310013
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 41 YR
• Patient Weight: 113