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

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).

• Brand Name: PEDICLE SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): JOHNSON AND JOHNSON / DEPUY SPINE, INC.
• MDR Report Key: 11929689
• MDR Text Key: 254268603
• Report Number: MW5101669
• Device Sequence Number: 1
• Product Code: NKB
• Reporter Country Code: SF
• Number of Events Reported: 1
• 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 Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 32 YR
• Patient Weight: 98