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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 16460500
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2020
Event Type  malfunction  
Manufacturer Narrative
Radiographs provided confirm the alleged malfunction. It is unknown if fusion had been completed. It is unknown if the patient followed post-operation restrictions or suffered a fall. The post-operative left rod fracture was not returned for evaluation. The fractured distal portion of the rt rod and associated fractured screw were returned and evaluated. Examination confirmed fracture initiated from notching incurred during initial usage where tulip was locked down and suggest the root cause is a result of reuse fatigue damage and or excessive force. The root cause of the post-operative screw and rod fracture was unable to be determine though radiographs and screw fracture evaluation point to extreme force which suggest excessive loading due to anatomical challenges or excessive force from a possible unreported fall. No additional investigation can be completed at this time. Labeling review: ". Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s). " ". Warnings, cautions and precautions: these devices can break when subjected to the increased load associated with delayed union or nonunion. Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs. If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break. " ". Patient education: the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components. The patient must be made aware that implant components may bend, break or loosen. " ". Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration well as to other complications. " ". Single use: reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachables, and transmission of infectious agents. Resterilization may result in damage or decreased performance. ".
 
Event Description
On (b)(6) 2019 a patient underwent a posterior fixation procedure without a reported issue. On (b)(6) 2020 a revision surgery was performed due to a broken rod and during the procedure a rod broke and screw fractured at s1 and were replaced. No patient injury reported.
 
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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 Key10922884
MDR Text Key218955761
Report Number2031966-2020-00212
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K143684
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 11/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16460500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/05/2020
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 Initial

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