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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUMMIT MEDICAL LTD. CLEAR MIX VACUUM MIXING SYSTEM; DISPENSER, CEMENT

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SUMMIT MEDICAL LTD. CLEAR MIX VACUUM MIXING SYSTEM; DISPENSER, CEMENT Back to Search Results
Model Number 414702
Device Problem Explosion (4006)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
Event Type  malfunction  
Event Description
A clear mix vacuum mixing system "exploded" during the case while mixing bone cement.Some of the bone cement is on the instruments and trials and cannot be removed.No harm to patient.A new disposable and more bone cement was mixed to replace the failed mixture.Manufacturer response for clear mix vacuum mixing system, (brand not provided) (per site reporter).We have requested they replace the failed product and the damaged instruments.
 
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Brand Name
CLEAR MIX VACUUM MIXING SYSTEM
Type of Device
DISPENSER, CEMENT
Manufacturer (Section D)
SUMMIT MEDICAL LTD.
929 west sunset blvd
suite 21-278
st george UT 84770
MDR Report Key11444506
MDR Text Key238625671
Report Number11444506
Device Sequence Number1
Product Code KIH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number414702
Device Catalogue Number414702
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/10/2021
Event Location Hospital
Date Report to Manufacturer03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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