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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REV LOCKING SCREW
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EXACTECH, INC. EQUINOXE; REV LOCKING SCREW Back to Search Results
Model Number 320-15-05
Device Problem Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.Concomitant medical products: equinoxe reverse 38mm glenosphere (320-01-38, (b)(4)), equinoxe reverse 38mm humeral liner +0 (320-38-00, (b)(4)).
 
Event Description
Approximately 6 weeks postoperative a left shoulder implant, the (b)(6) male experienced a revision due to the glenosphere is loose due to cross threaded glenosphere screw.Patient was last known to be in stable condition following the event.Devices were disposed of by the hospital.
 
Manufacturer Narrative
Based on previous similar investigations, the revision due to glenosphere locking screw malfunction and subsequent loosening reported was most likely due to the glenosphere not being fully seated on the reverse glenoid plate at the time of implantation and subsequent off-axis engagement of the glenosphere locking screw.However, this cannot be confirmed as the device was not returned for evaluation.
 
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Brand Name
EQUINOXE
Type of Device
REV LOCKING SCREW
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key9749894
MDR Text Key189472949
Report Number1038671-2020-00216
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862086495
UDI-Public10885862086495
Combination Product (y/n)N
PMA/PMN Number
K063569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number320-15-05
Device Catalogue Number320-15-05
Was Device Available for Evaluation? No
Date Manufacturer Received03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age74 YR
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