MAUDE Adverse Event Report: PEEK SPACERS; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problems Failure To Adhere Or Bond (1031); Positioning Problem (3009)

Patient Problems Cerebrospinal Fluid Leakage (1772); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 11/15/2003

Event Type  Injury  

Event Description

I had lumbar fusion surgery l4 l5 s1 woke up leaking csf and fusion screw lower right side spinal canal, then after 12 days i was sent home.Dr.(b)(6) abandoned and (b)(6) hospital of (b)(6) after having me sign stacks of test consents tricked me on (b)(6) 2003 in signing a release form so on (b)(6) 2003 i was put in a taxi and sent home to die.I was unable to walk without crutches.The surgery partly sealed but i was still leaking csf and spinal screw was still in my lumbar nerve roots.I later made it to dr.(b)(6) my butcher's (b)(6) assistant who was able to save my life, by then my mind was damaged and had no idea what was going on or why was part of my mind missing and they never told me.I used peek and cerasorb in lumbar spine or other materials in upper spine and neck.The story or nightmare still goes on.I need fda investigation.Please help me.Is the product compounded: no.Is the product over-the-counter: no.I have had many mri's but the last one magnevist almost killed me (b)(6) 2010 causing cerasorb to spread in me, paid my (b)(6) which are friends with (b)(6) hospital of (b)(6) owner (b)(6) and not one doctor ever reported any adverse events and of getting help after employees of (b)(6) hospital of (b)(6) agreed to help me - it was sold to (b)(6).

• Brand Name: PEEK SPACERS
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• MDR Report Key: 6427434
• MDR Text Key: 70791539
• Report Number: MW5068601
• Device Sequence Number: 2
• Product Code: MAX
• 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: 03/19/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Life Threatening; Other; Disability
• Patient Age: 38 YR
• Patient Weight: 107