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

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.

• Brand Name: SEE EVENT DESCRIPTION FOR LIST
• Type of Device: SURGICAL INSTRUMENTATION
• Manufacturer (Section D): NUVASIVE; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 2412912
• MDR Text Key: 17096630
• Report Number: 2412912
• Device Sequence Number: 1
• Product Code: MQP

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/06/2012
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: INVALID DATA
• Device MODEL Number: SEE 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 FDA: 01/06/2012
• Event Location: Hospital