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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT
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EXACTECH, INC. EQUINOXE; EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT Back to Search Results
Catalog Number 300-20-02
Device Problem Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2017.The prosthesis was discovered to be sitting proud and therefore had to be revised.
 
Manufacturer Narrative
Engineering evaluation noted that the revision reported was likely the result of implanting an oversized humeral stem, which led to the humeral stem sitting proud.However, this cannot be confirmed as the devices were not available for evaluation and x-rays were not provided.
 
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Brand Name
EQUINOXE
Type of Device
EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th court
gainesville, FL 32653
3523771140
MDR Report Key8270296
MDR Text Key133841647
Report Number1038671-2019-00009
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number300-20-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/10/2019
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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