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U.S. Department of Health and Human Services

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

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PEDICLE SCREW FOR SPINAL FUSION THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
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).

 
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Brand NamePEDICLE SCREW FOR SPINAL FUSION
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
MDR Report Key8966060
MDR Text Key157067603
Report NumberMW5089598
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 08/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2019
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
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: 09/04/2019 Patient Sequence Number: 1
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