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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. TORQUE SCREW

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EXACTECH, INC. TORQUE SCREW Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 02/01/2016
Event Type  Injury  
Manufacturer Narrative
The case report form indicates these events are definitely not related to devices and procedure.This event report was received through clinical data collection activities.Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2015.Revision due to aseptic loosening.
 
Manufacturer Narrative
The case report form indicates these events are definitely not related to devices and procedure.This event report was received through clinical data collection activities.Engineering evaluation noted that the revision reported was likely the result of aseptic loosening of the glenoid component, humeral component, or both.However, this cannot be confirmed as the devices were not available for evaluation and no further information was provided.
 
Event Description
Index surgery: (b)(6) 2015.Revision due to aseptic glenoid loosening.
 
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Brand Name
TORQUE SCREW
Type of Device
TORQUE SCREW
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th court
gainesville, FL 32653
MDR Report Key7693969
MDR Text Key114169803
Report Number1038671-2018-00600
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/17/2018
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 Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/16/2018
Initial Date FDA Received07/17/2018
Supplement Dates Manufacturer Received07/16/2018
Supplement Dates FDA Received08/17/2018
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 Age69 YR
Patient Weight78
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