MAUDE Adverse Event Report: DFINE INC. STABILIT ER2 BONE CEMENT, SINGLE LEVEL

Catalog Number 3366

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Pulmonary Embolism (1498)

Event Date 12/02/2014

Event Type  Injury  

Event Description

Date dfine became aware of incident was (b)(6) 2014 for complaint (b)(4).Fluoroscopically-guided single level thoracic t8 vertebral augmentation was performed on the patient on (b)(6) 2014 contributing to a cement embolism.The patient was prepped and draped in the usual sterile fashion, 1% lidocaine was used as local anesthetic.Under fluoroscopic guidance, a 10 gauge trocar-tipped needle was advanced into the t8 vertebral body using a right sided transpedicular approach.Cavity creation was performed using a coaxial osteotome.Polymethylmethacrylate cement was then injected under direct fluoroscopic visualization by the physician.Appropriate filling of the fracture plane along the inferior endplate, as well as the remainder of the vertebral body above the fracture, was observed.Approx 6cc of total cement was injected.A small amount of venous filling was seen along a tiny anterior lumbar vein, measuring less than 1mm in size.The physician noted no worrisome cement extravasation identified during the procedure.The needle was removed and a bandage was applied to the patient, with no initial complication.The patient was discharged home per protocol, with no complications.Post procedure after leaving the medical facility, the patient went to the er later that evening having shortness of breath following a recent vertebroplasty procedure; during a ct scan it was noted that the cement had continued through the vein into the patient's lung.Ct images were reviewed demonstrating a curvilinear calcific opacity in the distal aspect of the right main pulmonary artery was well as the distal pulmonary arterial branch is widely patent.A second smaller curvilinear thin cement embolism was also seen in one of the left lower lobe pulmonary arterial branches.Cement embolism is secondary to filling a very tiny approx.1mm thoracic paravertebral vein.The patient was eventually discharged without further symptoms, regarding shortness of breath.

Manufacturer Narrative

Stabilit er2 bone cement was implanted in the patient and not able to be returned for evaluation.Ifu 3380 revision ac, adverse events section.

• Brand Name: STABILIT ER2 BONE CEMENT, SINGLE LEVEL
• Type of Device: ER2 BONE CEMENT
• Manufacturer (Section D): DFINE INC.; 3047 orchard parkway; san jose CA 95134
• Manufacturer Contact: robert founds ; 3047 orchard parkway; san jose, CA 95134 ; 4083219999
• MDR Report Key: 4456941
• MDR Text Key: 5327036
• Report Number: 3006396387-2015-00002
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 3366
• Device Lot Number: DF051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TO PROCEDURE AND NEED FOR FURTHER PAIN MAINTENANCE; PATIENT F/U AT 1,7, AND 14 DAYS TO ASSESS RESPONSE
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR