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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON / DEPUY SPINE, INC. PEDICLE SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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JOHNSON AND JOHNSON / DEPUY SPINE, INC. PEDICLE SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problems Break (1069); Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)
Patient Problems Failure of Implant (1924); Muscle Weakness (1967); Pain (1994)
Event Date 10/20/2020
Event Type  Injury  
Event Description
I had a spinal fusion done in (b)(6) 2020 and a unique pedicle screw was inserted into the spine. Fast forward a couple months to (b)(6) 2020 and making a cup of tea, i reached out to grab a tea bag and heard a loud snapping noise and instantly fell weak in my lower back and legs, saw my dr at the earliest convenience which was about 10 days after which was filled with excruciating pain and suffering. I then had imaging done and it revealed the tops of the screws broke off and were floating about the spine. We had to remove do a full fusion i'm now 7 months post op after that repair and i now have major noises and severe pain coming from the set of instruments in my spine, this johnson and johnson products have been nothing but pain, suffering and more pain coupled with the fact that my dr has since medically boarded me from working. The instruments that failed in (b)(6) 2020 were flown out to america for testing of which i have not received any results from them nor will they accept responsibility. Fda safety report id # (b)(4).
 
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Brand NamePEDICLE SCREW
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
JOHNSON AND JOHNSON / DEPUY SPINE, INC.
MDR Report Key11929689
MDR Text Key254268603
Report NumberMW5101669
Device Sequence Number1
Product Code NKB
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/29/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 06/02/2021 Patient Sequence Number: 1
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