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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE HUMERAL ADAPTER TRAY
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EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE HUMERAL ADAPTER TRAY Back to Search Results
Catalog Number 320-10-10
Device Problem Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 08/06/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Revision due to disassociation.
 
Manufacturer Narrative
The engineering evaluation noted in the reported revision was likely the result of not fully seating the humeral liner at the time of implantation, which allowed for the loner to disassociate from the adapter tray.Initial awareness date in the initial submission should have been 06-aug-2018.
 
Event Description
Revision due to disassociation.
 
Event Description
Revision due to disassociation.
 
Manufacturer Narrative
The engineering evaluation noted in the reported revision was likely the result of not fully seating the humeral liner at the time of implantation, which allowed for the loner to disassociate from the adapter tray.
 
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Brand Name
EQUINOXE
Type of Device
EQUINOXE REVERSE HUMERAL ADAPTER TRAY
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7769024
MDR Text Key116628175
Report Number1038671-2018-00657
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K063569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/12/2023
Device Catalogue Number320-10-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2018
Initial Date Manufacturer Received 08/08/2018
Initial Date FDA Received08/09/2018
Supplement Dates Manufacturer Received08/14/2019
08/27/2019
Supplement Dates FDA Received08/21/2019
08/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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