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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. KERRISON RONGEUR RONGEUR, MANUAL

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NUVASIVE, INC. KERRISON RONGEUR RONGEUR, MANUAL Back to Search Results
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 02/22/2021
Event Type  malfunction  
Event Description
Nuvasive kerrison rongeur tip broke off during anterior interbody fusion procedure (alif). Broken tip accounted for and equipment sequestered. Fda safety report id# (b)(4).
 
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Brand NameKERRISON RONGEUR
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
NUVASIVE, INC.
MDR Report Key11595975
MDR Text Key243430596
Report NumberMW5100418
Device Sequence Number1
Product Code HAE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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