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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR22

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NUVASIVE, INCORPORATED NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR22 Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Thrombosis (2100)
Event Date 10/11/2019
Event Type  Injury  
Manufacturer Narrative
No product has been returned for evaluation as no product malfunction alleged. No radiographs or images were provided to confirm the alleged event. Even though root cause cannot be confirmed based on information provided the potential root cause may be related to patient condition and or surgical procedure. Labeling review: ". Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels. " device still in-situ.
 
Event Description
On (b)(6) 2019 patient underwent spinal procedure at l2-s1 levels. As per reporter on (b)(6) 2019, the patient developed a superficial deep vein thrombosis in their right lower leg. The patient was experiencing leg pain. The patient was treated with medications and it was reported to have resolved on (b)(6) 2019.
 
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Brand NameNUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT
Type of DeviceINTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR22
Manufacturer (Section D)
NUVASIVE, INCORPORATED
7475 lusk blvd.
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 Key10538982
MDR Text Key207138074
Report Number2031966-2020-00184
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203201
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received08/18/2020
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 Invalid Data

Patient Treatment Data
Date Received: 09/16/2020 Patient Sequence Number: 1
Treatment
8221055P2
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