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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL ADAPTER TRAY
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EXACTECH, INC. EQUINOXE REVERSE HUMERAL ADAPTER TRAY Back to Search Results
Catalog Number 320-10-00
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 01/29/2014
Event Type  Injury  
Event Description
Index surgery: (b)(6) 2012.Non-revision due to malunion of scapula fracture.This event report was received through clinical data collection activities.
 
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Engineering evaluation noted that the surgeon stated that the malunion of the scapular fracture reported was "definitely not related" to the device or procedure and can be attributed to another unknown event.
 
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Brand Name
EQUINOXE REVERSE HUMERAL ADAPTER TRAY
Type of Device
HUMERAL ADAPTER TRAY
Manufacturer (Section D)
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 n.w. 66th ct.
gainesville, FL 32653
MDR Report Key4947298
MDR Text Key6254273
Report Number1038671-2015-00345
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/23/2015
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 Catalogue Number320-10-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/23/2015
Initial Date FDA Received07/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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