MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. UNKNOWN VITALITY ILIAC SCREW; VITALITY SPINAL FIXATION SYSTEM

Device Problem Osseointegration Problem (3003)

Patient Problem No Code Available (3191)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2020-00517 to 3012447612-2020-00526.

Event Description

It was report that a patient underwent a revision surgery due to psuedoarthosis.No further surgical or patient information was provided.This is report one of ten for this event.

Manufacturer Narrative

Information added to h6: component codes, type of investigation, investigation findings, investigation conclusions.This follow-up report is being submitted to relay additional information.Summary: the complaint is confirmed for revision surgery due to pseudoarthrosis.Medical records were not provided for review.Device evaluation: product was not returned so a device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to patient conditions, traumatic event, or factors from the operation or product that were not provided by the complainant.Dhr review and related actions: dhr review could not be performed due to lack of lot information.No actions required.Device use : this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was report that a patient underwent a revision surgery due to pseudoarthrosis.No further surgical or patient information was provided.This is report one of ten for this event.

• Brand Name: UNKNOWN VITALITY ILIAC SCREW
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10520510
• MDR Text Key: 206489729
• Report Number: 3012447612-2020-00517
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention