MAUDE Adverse Event Report: NUVASIVE, INC. PEDICLE SCREWS; THORACOLUMBOSACRAL PEDICAL SCREW SYSTEM

Device Problem Break (1069)

Patient Problems Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Disability (2371); Ambulation Difficulties (2544)

Event Date 06/17/2017

Event Type  Injury  

Event Description

Back surgery l5/s1.Pedicle screws broke within the 1st 10 days; had 4 surgeries since and i'm disabled.Had surgery on l5-s1, (b)(6) 2017, after the pain meds worn off i had to tie a rope around the door hedge and put it over my walker to get out of bed every day.Then i would sit on an ice pack for 1/2 of the day.In (b)(6) 2017 surgeon fixed that, but i was left with chronic pain to this day.I've had (3) pain shots, acupuncture, neural prolotherapy, massage therapy and physical therapy sessions.Tried all kinds of over the counter patches and creams, electric stimulators and cbd's.So many x-rays, and catscans and dr visits to count, it's been 3 yrs of medical hell.I've had one pain pump test and failed; i had urinary retention and had to go to the er for catheterization.I have another test coming up to use a different meds.After the screws broke, i had severe sciatica down the right leg, surgery in (b)(6) 2017 to fix that (didn't work).Reconstructive surgery in (b)(6) 2017, fixed that but still had chronic nerve damage, back pain, and still have to this day.Operations (b)(6) 2019 and (b)(6) 2019, to repair bone growth, issues with l4/l5 (thought that maybe because of chronic pain.) there's too much scar tissue in my back now for any fix.Currently looking at pain pump optional.

• Brand Name: PEDICLE SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.
• MDR Report Key: 9646751
• MDR Text Key: 177387566
• Report Number: MW5092618
• Device Sequence Number: 3
• Product Code: NKB
• Combination Product (y/n): N
• 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: 01/18/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 77 YR
• Patient Weight: 83