MAUDE Adverse Event Report: BENVENUE MEDICAL KIVA; SPINE AUGMENTATION COIL

Model Number KIVA2200

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

Kiva spine augmentation coil fatigued (did not maintain its shape) after multiple attempts to deploy into vertebral body (l2).

• Brand Name: KIVA
• Type of Device: SPINE AUGMENTATION COIL
• Manufacturer (Section D): BENVENUE MEDICAL; santa clara CA 95054
• MDR Report Key: 4825077
• MDR Text Key: 5905585
• Report Number: MW5042956
• Device Sequence Number: 1
• Product Code: OCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 05/29/2015

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: Health Professional
• Device Model Number: KIVA2200
• Device Lot Number: 15057009
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR