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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; SINGLE USE INSTRUMENT TRAY
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; SINGLE USE INSTRUMENT TRAY Back to Search Results
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 05/05/2022
Event Type  malfunction  
Event Description
Dynanail ttc fusion system, loaner tray found with bioburden in instrumentation.Tray not used.
 
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Type of Device
SINGLE USE INSTRUMENT TRAY
MDR Report Key15885709
MDR Text Key304892794
Report Number15885709
Device Sequence Number1
Product Code OJV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/01/2022
Event Location Hospital
Date Report to Manufacturer11/30/2022
Type of Device Usage Unknown
Patient Sequence Number1
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