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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE COMPONENTS
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EXACTECH, INC. EQUINOXE COMPONENTS Back to Search Results
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Disorder (2373); Joint Dislocation (2374); No Information (3190)
Event Date 01/09/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Revision due to dislocation.
 
Manufacturer Narrative
Pending evaluation.Updated report with additional information.
 
Event Description
Revision due to dislocation.There was a one and half hour delay to surgery.
 
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly.This device is used for treatment not diagnosis.
 
Event Description
This report is for a revision due to dislocation, reason unknown.The reported delay was not related to this device.It will be reported on an additional mfr # 1038971-2018-50003 and mfr # 1038671-2018-50004.
 
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Brand Name
EQUINOXE COMPONENTS
Type of Device
EQUINOXE COMPONENTS
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7241264
MDR Text Key99032899
Report Number1038671-2018-00034
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 12/19/2018
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 Physician
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/12/2018
Initial Date FDA Received02/05/2018
Supplement Dates Manufacturer Received01/12/2018
12/18/2018
Supplement Dates FDA Received06/04/2018
12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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