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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 01/18/2021
Event Type  Death  
Manufacturer Narrative
No product was returned as no malfunction was alleged. Due to lack of information, the root cause cannot be determined, however review of the reported event indicates the patient's medical history and response to a technically demanding surgery is most likely the root cause. No additional investigation can be completed. Labeling review: ". Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery. Potential risks identified with the use of this system, which may require additional surgery, include: death. ". ". Warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. ". ". Patient education: preoperative instructions to the patient are essential. The patient should be made aware of the limitations of the implant and potential risks of the surgery. ". ". Contraindications: contraindications include but are not limited to:6. Patients with physical or medical conditions that would prohibit beneficial surgical outcome.
 
Event Description
On (b)(6) 2021, a patient underwent a posterior fixation procedure at l2/s1. The surgery was reportedly successfully completed. After the patient awakened from anesthesia, a thrombus developed and the patient went into cardiac arrest. The patient was transferred to the icu, but unfortunately passed away on (b)(6) 2021. The physician suggests that there was no causal relationship between the decease and nuvasive products.
 
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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 Key11280349
MDR Text Key230310981
Report Number2031966-2021-00024
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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? 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 Received01/22/2021
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: 02/04/2021 Patient Sequence Number: 1
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