MAUDE Adverse Event Report: IZI MEDICAL PRODUCTS LLC KIVA VCF TREATMENT SYSTEM KIT FIRST FRACTURE- LEFT; CEMENT, BONE, VERTEBROPLASTY

Lot Number 20201889, 19000800

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

T12 kyphoplasty was complicated by two failures of kiva vcf treatment kit system: first kit inner portion of cannula could not be placed on device; second kit 1x1mm portion of plastic cage was stuck within vertebral body.Fda safety report id# (b)(4).

• Brand Name: KIVA VCF TREATMENT SYSTEM KIT FIRST FRACTURE- LEFT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): IZI MEDICAL PRODUCTS LLC
• MDR Report Key: 10683361
• MDR Text Key: 211694885
• Report Number: MW5097224
• Device Sequence Number: 1
• Product Code: NDN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 20201889, 19000800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 82