MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Model Number 204H0300

Patient Problem Failure of Implant (1924)

Event Date 10/20/2023

Event Type  Injury  

Event Description

Lumbar curve has overcorrected enough since her last follow-up visit for the cobb angle to equal 30 degrees.The plan is to revise the surgery to decrease the amount of overcorrection.Plan for revision is to have her start on her left side to remove the tether from t11-t12, t12-l1 then flip her over and place screws at t12, l1, l2 and replace the entire rope on the right side from t5-l2 to correct this large curve.This required about 2 days inpatient.

• Brand Name: THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
• Type of Device: VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; westminster CO 80021
• MDR Report Key: 18347261
• MDR Text Key: 330887048
• Report Number: MW5149327
• Device Sequence Number: 1
• Product Code: QHP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 204H0300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White