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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE GLENOSPHERE LOCKING SCREW

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EXACTECH, INC EQUINOXE REVERSE GLENOSPHERE LOCKING SCREW Back to Search Results
Catalog Number 320-15-05
Device Problem Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 05/31/2016
Event Type  malfunction  
Manufacturer Narrative
Engineering evaluation noted that the revision reported was likely the result of not fully seating the torque defining screw during the initial implantation, which prevented the humeral liner from fully assembling to the adapter tray, leading to disassociation.Associated with 1038671-2016-00396, 1038671-2016-00495, 1038671-2016-00496, and 1038671-2016-00625.
 
Event Description
Index surgery: (b)(6) 2013.Revision of reverse shoulder components three years after original surgery due to humeral tray disassociation.
 
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Brand Name
EQUINOXE REVERSE GLENOSPHERE LOCKING SCREW
Type of Device
SCREW
Manufacturer (Section D)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th ct
gainesville, FL 32653
3523771140
MDR Report Key5976482
MDR Text Key55597084
Report Number1038671-2016-00626
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 Other
Type of Report Initial
Report Date 09/26/2016
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
Device Catalogue Number320-15-05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/26/2016
Initial Date FDA Received09/26/2016
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;
Patient Age75 YR
Patient Weight120
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