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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BENVENUE MEDICAL KIVA KYPHOPLASTY ; VCF TREATMENT SYSTEM (KYPHOPLASTY)
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BENVENUE MEDICAL KIVA KYPHOPLASTY ; VCF TREATMENT SYSTEM (KYPHOPLASTY) Back to Search Results
Model Number KIV2200
Device Problems Collapse (1099); Structural Problem (2506); Unintended Movement (3026)
Patient Problems Paralysis (1997); Paraplegia (2448)
Event Date 08/26/2015
Event Type  Injury  
Event Description
A (b)(6) patient had a left transpedicular vertebral kiva kyphoplasty procedures on t6.Three weeks after the procedure, the patient presented to the ed with intractable back pain and respiratory difficulty.At four weeks post procedure, the patient was transferred to an inpatient rehab/skilled nursing facility.After one week at the rehab facility, the patient returned to the hospital and informed the physician a loss of movement in her legs occurred eight days prior.A ct thoracic spine noted postvertebroplasty changes including new retropulsion.Neurosurgery performed a decompressive laminectomy of t6 and fusion of t4-t8.Post-operatively, the patient has limited sensation and no movement of both lower extremities.
 
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Brand Name
KIVA KYPHOPLASTY
Type of Device
VCF TREATMENT SYSTEM (KYPHOPLASTY)
Manufacturer (Section D)
BENVENUE MEDICAL
santa clara CA 95054
MDR Report Key5145186
MDR Text Key28148911
Report Number5145186
Device Sequence Number1
Product Code NDN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Physician
Report Date 09/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberKIV2200
Device Lot Number15190010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/03/2015
Event Location Nursing Home
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age68 YR
Patient Weight101
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