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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVALIGN GERMANY SPECIALITY INSTRUMENTS MILLENNIUM MICROPITUITARY RONGEUR

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AVALIGN GERMANY SPECIALITY INSTRUMENTS MILLENNIUM MICROPITUITARY RONGEUR Back to Search Results
Model Number 9560565
Device Problem Material Fragmentation (1261)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Unable to confirm lot number of this device. Trend analysis completed; device history record review not possible as lot number could not be confirmed.
 
Event Description
During a lumber fusion surgical procedure the micropituitary rongeur broke, a fragment broke off, surgeon was able to retrieve the fragment.
 
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Brand NameMILLENNIUM
Type of DeviceMICROPITUITARY RONGEUR
Manufacturer (Section D)
AVALIGN GERMANY SPECIALITY INSTRUMENTS
626 cooper ct
schaumburg IL 60173
MDR Report Key11393372
MDR Text Key246274467
Report Number1421101-2021-00001
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9560565
Device Catalogue Number31-9560565
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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