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U.S. Department of Health and Human Services

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

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NUVASIVE, INC. THORACOLUMBOSACRAL PEDICLE SCREW Back to Search Results
Model Number 7880042
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problems Pain (1994); Disability (2371); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165)
Event Date 06/17/2019
Event Type  Injury  
Event Description

Ten days after surgery two screws broke and are unable to be removed due to it will cause more damage. Reporter has had several surgeries since the initial, and states that he lives in pain everyday, is disabled and unable to walk without pain.

 
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Brand NameTHORACOLUMBOSACRAL PEDICLE SCREW
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW
Manufacturer (Section D)
NUVASIVE, INC.
MDR Report Key9279478
MDR Text Key165227108
Report NumberMW5090865
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
Type of Report Initial
Report Date 11/04/2019
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received11/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number7880042
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
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: 11/04/2019 Patient Sequence Number: 1
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