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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SEE EVENT DESCRIPTION FOR LIST SURGICAL INSTRUMENTATION

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NUVASIVE SEE EVENT DESCRIPTION FOR LIST SURGICAL INSTRUMENTATION Back to Search Results
Model Number SEE EVENT DESCRIPTION FOR LIST
Device Problems Device Reprocessing Problem (1091); Structural Problem (2506)
Patient Problem No Patient Involvement (2645)
Event Date 01/04/2012
Event Type  Malfunction  
Event Description

Director of central sterile storage reports design issues with the instruments noted in this report. Instruments cannot be disassembled for cleaning and sterilization. Notification of nuvasive resulted in meeting with company's design engineer. Currently the instruments are being redesigned and the intruments listed in this report are the "old" design. Instrumentation list: coroent xl inserter,coroent xl inserter angled, coroent xl wide inserter, inserter large oblique, inserter coroent li, screwdriver 5. 5mm, coroent inserter larger oblique, coroent li inserter short, rod inserter 5. 5mm , 90 deg inserter, dbr ii guide, alternate rod delivery guide, freehand inserter, dts inserter, freehand angled driver,dts angled driver, self centering awl, angled awl, drill guide, bone screw extractor, coroent xl-f inserter, coroent xl-f implant inserter, coroent xl-f implant inserter, coroent xl-f implant inserter, coroent xl-f implant inserter, coroent xl-f implant inserter, coroent xl-f implant inserter, screwdriver, drill guide awl, fixed self centering awl, self centering awl, self centering drill, bolt driver, xlp plus screwdriver, pin inserter, pivoting plate inserter, guided straight driver, straight awl, straight drill, trial removal tool, angled driver short, angled driver retaining, angled driver non-retaining, solid driver self retaining, solid driver non retaining, solid driver ball end, angled awl, angled awl, medial grip implant inserter, implant inserter large, implant inserter small.

 
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Brand NameSEE EVENT DESCRIPTION FOR LIST
Type of DeviceSURGICAL INSTRUMENTATION
Manufacturer (Section D)
NUVASIVE
7475 lusk blvd
san diego CA 92121
MDR Report Key2412912
MDR Text Key17096630
Report Number2412912
Device Sequence Number1
Product Code MQP
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 01/05/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/06/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator INVALID DATA
Device MODEL NumberSEE EVENT DESCRIPTION FOR LIST
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/06/2012
Event Location Hospital

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