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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 9560565
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2020
Event Type  malfunction  
Event Description
During a lumber fusion surgical procedure the micro pituitary rongeur broke, a fragment broke off, surgeon was able to retrieve the fragment.
 
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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 Key11045698
MDR Text Key222677670
Report Number11045698
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/09/2020,11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9560565
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2020
Event Location No Information
Date Report to Manufacturer12/21/2020
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 Unkown

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