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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID
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EXACTECH, INC. EQUINOXE; GLENOID Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2019
Event Type  Injury  
Manufacturer Narrative
This event report was received through clinical data collection activities.Pending evaluation.
 
Event Description
Asceptic glenoid loosening and osteolysis around cage and screws.(b)(6) years old patient, refuses revision surgery.The case report form indicates this event is unlikely related to devices and definitely not related to procedure.
 
Manufacturer Narrative
The adverse event reported was likely the result of an insufficient bond between the glenoid baseplate and the bone, which led to aseptic (non-infected) glenoid loosening and osteolysis.However, this cannot be confirmed as the devices were not available for evaluation.
 
Manufacturer Narrative
The aseptic (non-infected) glenoid loosening and osteolysis reported was likely the result of an insufficient bond between the glenoid baseplate and the bone.However, this cannot be confirmed as the devices were not available for evaluation.
 
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Brand Name
EQUINOXE
Type of Device
GLENOID
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key8662867
MDR Text Key146807564
Report Number1038671-2019-00320
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 health professional
Type of Report Initial,Followup,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Distributor Facility Aware Date05/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight51
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