MAUDE Adverse Event Report: BENVENUE MEDICAL, INC. BLAZER-C VERTEBRAL AUGMENTATION SYSTEM

Catalog Number BCN3120

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/26/2014

Event Type  Injury  

Event Description

Patient had thoracic (t6) vertebral compression fracture, has been getting chemotherapy, radiation and taking bisphosphonates for cancer treatment.As the surgeon accessed the t6 pedicle with the working cannula, it was apparent that the patient's bone was extremely hard.The surgeon applied quite a bit of force to the cannula while manipulating the cannula to change the direction.As a result of the excessive force, manipulation and torque, the working cannula was bent and eventually broke during the maneuver with 1-2 cm protruding posteriorly from the pedicle but still subcutaneous.The surgeon was still able to inject the bone cement successfully using the blazer-c device completing the vertebral augmentation procedure.The working cannula was cut at the posterior border of the pedicle after further tries to remove it, and a partial piece of the cannula remains securely in the pedicle.The surgeon did not allege a deficiency in the performance of the device and indicates no further patient effect.In the surgeon's opinion, the blazer-c procedure is a clear clinical benefit to the patient.The product has been received for analysis.

Manufacturer Narrative

Evaluation summary: the working cannula remnant was returned.Investigation of the returned product was conducted and the reported event was confirmed.Based on the analysis, the breakage was initiated by torsional buckling evident by the "barber pole" shape left on cannula piece.The investigation however could not replicate the reported event in a testing environment.The investigation concluded that the cause of the reported event was due to the use of the access tools exceeded the working cannula torsional strength.In this case the patient presented an unusual demanding hard bone condition, as stated by the surgeon.Review of the device history record confirmed that this device passed all inspection requirements.There were no non-conformances identified for this lot that would have contributed to the reported event.There is no information that indicates evidence of product deficiency.This represents an isolated occurrence; therefore no corrective action will be implemented.Benvenue will continue to monitor these types of incidents and take the necessary steps to correct any future findings.

• Brand Name: BLAZER-C VERTEBRAL AUGMENTATION SYSTEM
• Manufacturer (Section D): BENVENUE MEDICAL, INC.; santa clara CA 95054
• Manufacturer Contact: anil patel ; 3052 bunker hill lane, suite 120; santa clara, CA 95054 ; 4084549323
• MDR Report Key: 4377208
• MDR Text Key: 15127161
• Report Number: 3007033608-2014-00004
• Device Sequence Number: 1
• Product Code: OCJ
• Combination Product (y/n): N
• PMA/PMN Number: K070293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2005
• Device Catalogue Number: BCN3120
• Device Lot Number: 14008001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2014
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other