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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE TORQUE DEFINING SCREW ASSEMBLY

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EXACTECH, INC EQUINOXE REVERSE TORQUE DEFINING SCREW ASSEMBLY Back to Search Results
Catalog Number 320-11-00
Device Problem Material Separation (1562)
Patient Problem Fall (1848)
Event Date 09/07/2016
Event Type  malfunction  
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
 
Event Description
Index surgery: (b)(6) 2014.Revision of shoulder components due to poly disengagement as a result of a fall.This event report was received through clinical data collection activities.
 
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Brand Name
EQUINOXE REVERSE TORQUE DEFINING SCREW ASSEMBLY
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 Key5993142
MDR Text Key56161609
Report Number1038671-2016-00630
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 Other
Type of Report Initial
Report Date 10/03/2016
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 Number320-11-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/27/2016
Initial Date FDA Received10/03/2016
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 Age68 YR
Patient Weight95
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