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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE GLENOID PLATE
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EXACTECH, INC. EQUINOXE REVERSE GLENOID PLATE Back to Search Results
Catalog Number 320-15-01
Device Problem Insufficient Information (3190)
Patient Problems Numbness (2415); Ambulation Difficulties (2544)
Event Date 03/19/2014
Event Type  Injury  
Event Description
Revision of equinoxe shoulder components due patient having numbness and limitations in motion.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.Further, device specific information was not provided, precluding a device history record search.
 
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Brand Name
EQUINOXE REVERSE GLENOID PLATE
Type of Device
REVERSE GLENOID PLATE
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 Key4054077
MDR Text Key20015255
Report Number1038671-2014-00405
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
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 08/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number320-15-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/21/2014
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) Hospitalization; Required Intervention;
Patient Age70 YR
Patient Weight91
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