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U.S. Department of Health and Human Services

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

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NUVASIVE, INC. PEDICLE SCREWS THORACOLUMBOSACRAL PEDICAL SCREW SYSTEM Back to Search Results
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.

 
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Brand NamePEDICLE SCREWS
Type of DeviceTHORACOLUMBOSACRAL PEDICAL SCREW SYSTEM
Manufacturer (Section D)
NUVASIVE, INC.
MDR Report Key9646751
MDR Text Key177387566
Report NumberMW5092618
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/29/2020 Patient Sequence Number: 1
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