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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL INSERT FB SZ 2 RT 8MM
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EXACTECH, INC. VANTAGE; TIBIAL INSERT FB SZ 2 RT 8MM Back to Search Results
Catalog Number 350-22-22
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Cyst(s) (1800)
Event Date 01/31/2019
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2018.Surgical management on right ankle arthrotomy, with removal of distal tibial cyst and bone grafting.The case report form indicates this event is possibly related to devices and unlikely related to procedure.This event report was received through clinical data collection activities.
 
Manufacturer Narrative
Section h11: this mfr 1038671-2019-00184 has been submitted in error because this event does not provide an allegation against the device and is regarding surgical management of a cyst and bone graft that does not involve the implanted devices.This event does not meet the definition of a complaint.Please disregard.
 
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Brand Name
VANTAGE
Type of Device
TIBIAL INSERT FB SZ 2 RT 8MM
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key8451143
MDR Text Key139805965
Report Number1038671-2019-00184
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
Type of Report Initial,Followup
Report Date 11/12/2019
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
Device Catalogue Number350-22-22
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/27/2019
Initial Date FDA Received03/26/2019
Supplement Dates Manufacturer Received02/27/2019
Supplement Dates FDA Received11/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight71
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