MAUDE Adverse Event Report: PEDICLE SCREW FOR SPINAL FUSION; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Device Slipped (1584)

Patient Problem Disability (2371)

Event Date 08/29/2016

Event Type  Injury  

Event Description

I had a spinal fusion at stony brook university hosp by "dr brain morelia's." after 6 months he said the pedicure screws were backing out.I had to have a second surgery to replace hardware that has caused serious disability."dr (b)(6)" told me after second operation that he returned the hardware to mfr and they said it was a design flaw and hardware was not properly torqued.Fda safety report id# (b)(4).

• Brand Name: PEDICLE SCREW FOR SPINAL FUSION
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• MDR Report Key: 8966060
• MDR Text Key: 157067603
• Report Number: MW5089598
• Device Sequence Number: 1
• 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: 08/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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; Other; Disability
• Patient Age: 51 YR