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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 08/29/2019

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.This occurrence is the second event reported.The rep from zimmer biomet supplies the product for the surgeries.The hosp is not required to provide the product.Ref mw5090357.Fda safety report id#: (b)(4).

• Brand Name: VITALITY SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.
• MDR Report Key: 9192039
• MDR Text Key: 162442769
• Report Number: MW5090356
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR