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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPINE FUSION SYSTEMS: INSTRUMENTS X 8 IN 5 DIFFERENT TRAYS

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NUVASIVE SPINE FUSION SYSTEMS: INSTRUMENTS X 8 IN 5 DIFFERENT TRAYS Back to Search Results
Catalog Number 340035
Device Problems Device Reprocessing Problem (1091); Structural Problem (2506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2012
Event Type  No Answer Provided  
Event Description

"nuvasive spine systems are manufactured in a way that prevents adequate cleaning and disinfection". All instruments listed have either excessively fine cannulation or had an inner shaft that rotates with an external shaft: the instrument cannot be disassembled to allow each piece to be cleaned. This makes it next to impossible for the staff in csp to ensure that the instrumentation is clean and able to be sterilized for the next patient. " these are quotes by csp personnel at this facility. ====================== manufacturer response for spine fusion systems: instruments x 8 in 5 different trays, (brand not provided) per site reporter. ====================== vendor rep offers nuvasive central sterile processing staff to visit our facility and work with our central sterile processing staff for information sharing and education; both csp departments can discuss common issues, frustrations and share techniques.

 
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Type of DeviceSPINE FUSION SYSTEMS: INSTRUMENTS X 8 IN 5 DIFFERENT TRAYS
Manufacturer (Section D)
NUVASIVE
7475 lusk boulevard
san diego CA 92121
MDR Report Key2626270
MDR Text Key2726103
Report Number2626270
Device Sequence Number1
Product Code NKB
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 06/14/2012
8 DeviceS WERE Involved in the Event: 1   2   3   4   5   6   7   8  
0 PatientS WERE Involved in the Event:
Date FDA Received06/14/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator
Device Catalogue Number340035
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 FDA06/14/2012
Event Location Hospital

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