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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 Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Joint Dislocation (2374)
Event Date 11/08/2017
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Revision due to patient falling and dislocating.
 
Manufacturer Narrative
It is noted that excessive activity and trauma influence devices and can affect premature device failure.There is no indication that there is a device related problem/malfunction, there is no allegation against any device.The most likely cause of the reported event is related to the trauma and impact when the patient fell.This device is used for treatment not diagnosis.
 
Event Description
The outcome was noted to be successful.Associated mfrs: 1038671-2017-00832, 1038671-2017-00834.
 
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Brand Name
EQUINOXE REVERSE GLENOSPHERE LOCKING SCREW
Type of Device
GLENOSPHERE LOCKING SCREW
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7047966
MDR Text Key93189310
Report Number1038671-2017-00833
Device Sequence Number1
Product Code KWT
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
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date07/19/2022
Device Catalogue Number320-15-05
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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