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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE LOCKING CLIP

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EXACTECH, INC. VANTAGE LOCKING CLIP Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 08/09/2018
Event Type  Injury  
Manufacturer Narrative

Pending evaluation.

 
Event Description

Revision due to infection.

 
Manufacturer Narrative

Revision due to infection, likely caused by having a fresh wound at a music festival for a few days. Engineering evaluation noted that the revision reported was likely the result of an infection caused by an open wound. Infection is addressed in the product labeling under general surgical risks.

 
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Brand NameVANTAGE LOCKING CLIP
Type of DeviceLOCKING CLIP
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66rh court
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th court
gainesville, FL 32653
3523771140
MDR Report Key7957700
MDR Text Key123485714
Report Number1038671-2018-00803
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2018
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 TREATMENT DATA
Date Received: 10/11/2018 Patient Sequence Number: 1
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