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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 16191111
Device Problems Break (1069); Misassembled During Installation (4049)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 10/02/2019
Event Type  malfunction  
Manufacturer Narrative
No product has been returned for investigation as it remains in-situ. Radiographs provided confirm the alleged event. Labeling review: ". Warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure. All implants should be used only with the appropriately designated instrument. " ". Preoperative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient. " ". Note: check both reduction extensions after removal for the black lasermark at the distal end of the reduction extension to ensure the reduction extension has broken off at the correct spot (fig. 12). Note: be sure the lock screw is fully seated and the rod is fully reduced prior to breaking off the reduction extensions. ".
 
Event Description
On an unknown date a patient underwent a posterior procedure at l4-s1 without any reported incidents. During a postoperative visit the reduction extension tabs were discovered still in-situ. No revision procedure is currently planned.
 
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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 Key9703324
MDR Text Key183103422
Report Number2031966-2020-00027
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517655806
UDI-Public887517655806
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16191111
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 Received05/11/2020
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

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