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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. STABILIT COMPLETE FRACTURE KIT; CEMENT, BONE, VERTEBROPLASTY
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MERIT MEDICAL SYSTEMS, INC. STABILIT COMPLETE FRACTURE KIT; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 3506-01
Device Problem No Flow (2991)
Patient Problem No Information (3190)
Event Date 05/05/2017
Event Type  malfunction  
Event Description
During an l-1 kyphoplasty procedure, the cement would not flow out of the tubing of the fracture kit.Other kits were opened, and the procedure was then completed successfully.There were no complications.Note: there were three different kits opened before obtaining one in which the cement would flow freely.Manufacturer response for complete fracture kit, stabilit complete fracture kit (per site reporter): the vendor requested the kits be sent back for analysis.
 
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Brand Name
STABILIT COMPLETE FRACTURE KIT
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan UT 84095
MDR Report Key6685867
MDR Text Key79064982
Report Number6685867
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date07/31/2018
Device Catalogue Number3506-01
Device Lot NumberK1062641
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/14/2017
Event Location Hospital
Date Report to Manufacturer06/14/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age87 YR
Patient Weight55
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