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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC PITUITARY RONGEUR INSTRUMENT, CUTTING ORTHOPEDIC

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MEDTRONIC, INC. MEDTRONIC PITUITARY RONGEUR INSTRUMENT, CUTTING ORTHOPEDIC Back to Search Results
Model Number 00885074451183
Device Problems Break (1069); Component Missing (2306)
Patient Problem No Information (3190)
Event Date 06/26/2018
Event Type  Injury  
Event Description
During right lumbar 1-2 and left lumbar 4-5 microdiskectomy, a pituitary rongeur was noted missing a piece of the jaw. It had broken off and the fragment remained in the surgical site l1-l2. Attempts to retrieve the fragment with the use of fluoroscopy and endoscope into the disk space to no avail.
 
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Brand NameMEDTRONIC PITUITARY RONGEUR
Type of DeviceINSTRUMENT, CUTTING ORTHOPEDIC
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key7709857
MDR Text Key114838327
Report NumberMW5078504
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
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 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number00885074451183
Device Lot NumberGZ16JO23
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/20/2018 Patient Sequence Number: 1
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