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U.S. Department of Health and Human Services

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

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NUVASIVE INCORPORATED NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 15455500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seizures (2063); Reaction (2414)
Event Date 01/10/2018
Event Type  Injury  
Manufacturer Narrative
No product returned for evaluation as it remains in-situ, nor allegation of product malfunction. No revision procedure is planned at this time. Label review: ". Warnings, cautions and precautions: caution must be taken due to potential patient sensitivity to materials. Do not implant in patients with known or suspected sensitivity to the aforementioned materials. " ". Contraindications: contraindications include but are not limited to: infection, local to the operative site, signs of local inflammation, patients with known sensitivity to the materials implanted. ".
 
Event Description
Received information stating patient was experiencing severe allergic reactions post operative. Inquiry received, breakdown of the metals in each of the pieces utilized in the patient's procedure.
 
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Brand NameNUVASIVE RELINE SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
NUVASIVE INCORPORATED
7475 lusk boulevard
san diego CA 92121
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 Key9497776
MDR Text Key183098482
Report Number2031966-2019-00264
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517594204
UDI-Public887517594204
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number15455500
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 Received12/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/19/2019 Patient Sequence Number: 1
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