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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 13117545
Device Problem Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Event Description
On (b)(6) 2021 a patient underwent a extreme lateral interbody fusion procedure from l3 to l5 fixed with posterior fixation.On a unknown date it was discovered that the right screw at l5 was deviated inward.This deviation was confirmed to be the result of proper trajectory not being achieved in the index procedure.On (b)(6) 2021 a revision occurred where the deviated screw was re used and put in the proper position.The was no report of any adverse consequences to the patient as a result of the malplaced screw and the patient is considered to be recovering.
 
Manufacturer Narrative
The lot number was reported to be either n288197 or n295595.No product was returned as no product fault was alleged and the involved device remains in-situ.No radiographs could be provide showing the initial or revised construct confirming the complaint.No additional information could be obtained.The root cause is considered to be an inadvertent use error and the result of screw malplacement during the index 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." "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.".
 
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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
MDR Report Key12523456
MDR Text Key281870133
Report Number2031966-2021-00129
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517582782
UDI-Public887517582782
Combination Product (y/n)N
PMA/PMN Number
K143684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 09/23/2021
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 Number13117545
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/13/2021
Initial Date FDA Received09/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age69 YR
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