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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. VITALITY SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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ZIMMER BIOMET SPINE, INC. VITALITY SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Damage (2104)
Event Date 08/19/2019
Event Type  Injury  
Event Description
The pt underwent a spinal fusion where vitality screws were inserted. The pt required add'l surgical procedures for revision and removal of the vitality screws. The pt has had 4 surgeries within a year. The rep from zimmer biomet supplies the product for the surgeries. The hosp is not required to provide the product. Fda safety report id# (b)(4).
 
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Brand NameVITALITY SPINAL FIXATION SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE, INC.
MDR Report Key9193228
MDR Text Key162626403
Report NumberMW5090392
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/11/2019 Patient Sequence Number: 1
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