Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BENVENUE MEDICAL, INC. BLAZER; SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BENVENUE MEDICAL, INC. BLAZER; SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY Back to Search Results
Model Number BCN3120
Device Problems Break (1069); Unraveled Material (1664)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/28/2018
Event Type  malfunction  
Event Description
The attending, along with a fellow, were using the blazer-c from benvenue medical in the first lumbar vertebrae of the spine from a left pedicular access.The 11ga diamond tip single step introducer was advanced to the anterior portion of l1 vertebrae married with the 10ga working cannula.The 11ga diamond tip single step introducer was removed and the blazer c augmentation device was deployed.While advancing the blazer c's coil, the knob snapped.The blazer c was removed and the 10ga working cannula was to be removed.However, upon trying to retrieve the cannula, it started to unravel.The beveled tip was left in the l1 vertebral body but most of the cannula was removed.Manufacturer response for blazer c introducer kit, blazer c (per site reporter): do not have follow up from the manufacturer yet.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BLAZER
Type of Device
SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY
Manufacturer (Section D)
BENVENUE MEDICAL, INC.
5403 betsy ross dr
santa clara CA 95054
MDR Report Key7428338
MDR Text Key105399933
Report Number7428338
Device Sequence Number1
Product Code OCJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberBCN3120
Device Lot Number17006002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/29/2018
Event Location Hospital
Date Report to Manufacturer03/29/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
-
-