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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INCORPORATED THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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NUVASIVE, INCORPORATED THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
No product was returned as no malfunction was alleged and it is unknown if the devices utilized were nuvasive products. Due to lack of information, the root cause cannot be determined and no additional investigation can be completed.
 
Event Description
During investigation of complaint (b)(4), it was discovered a revision took on (b)(6) 2020 for an unknown reason and the product revised is unknown. It was not confirmed to be a nuvasive product. No additional info received.
 
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Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section G)
NUVASIVE, INCORPORATED
7475 lusk boulevard
san diego CA 92121
Manufacturer Contact
virnalisa cobacha
7475 lusk boulevard
san diego, CA 92121
MDR Report Key11280738
MDR Text Key245579255
Report Number2031966-2021-00025
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 Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/04/2021 Patient Sequence Number: 1
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