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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 13600000
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/16/2021
Event Type  malfunction  
Manufacturer Narrative
Product still in-situ and cannot be returned for investigation.No images provided to confirm the complaint.Patient is reportedly asymptomatic.It is unknown if the patient followed post-operative restrictions or suffered a fall.Due to lack of information, the root cause cannot be determined and 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: bending, fracture or loosening of implant component(s), loss of fixation." ".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.Care should be taken to insure that all components are ideally fixated prior to closure." ".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.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".
 
Event Description
On (b)(6) 2021, it was reported that there has been a metal noise when the patient sat in a chair.Ct scan shows no abnormalities and so there is no revision surgery planned for now.
 
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Brand Name
NUVASIVE RELINE SYSTEM
Type of Device
THORACOLUMBOSACRAL 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 Key11373308
MDR Text Key233322770
Report Number2031966-2021-00036
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517551719
UDI-Public887517551719
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K182974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number13600000
Device Lot NumberN23252
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/16/2021
Initial Date FDA Received02/24/2021
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 Sequence Number1
Patient Age80 YR
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