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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVALIGN TECHNOLOGIES, INC. MILLENNIUM RONGEUR, MANUAL

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AVALIGN TECHNOLOGIES, INC. MILLENNIUM RONGEUR, MANUAL Back to Search Results
Model Number 85-2481559
Device Problem Component Falling (1105)
Patient Problem No Information (3190)
Event Date 05/03/2018
Event Type  malfunction  
Event Description
A screw from the kerrison #3 fell out on the surgical field. The screw and the two separate portions of the instrument were removed from the surgical field and an x-ray of the surgical site was taken and read as clear by radiologist per policy.
 
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Brand NameMILLENNIUM
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
AVALIGN TECHNOLOGIES, INC.
8727 clinton park drive
fort wayne IN 46825
MDR Report Key7586219
MDR Text Key110600197
Report Number7586219
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number85-2481559
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2018
Event Location Hospital
Date Report to Manufacturer06/01/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/11/2018 Patient Sequence Number: 1
Treatment
NOT APPLICABLE.
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