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

Catalog Number 204H0300

Patient Problem Failure of Implant (1924)

Event Date 12/04/2023

Event Type  Injury  

Event Description

Dr.(b)(6) for the study and the surgeon, recommended surgical intervention to release the tether system from t5-t6 to allow everything to straighten out from overcorrection.Dr.(b)(6) thinks the top two screws of the tether system from zimmer biomet may be contributing to the subject's overcorrection.

• Brand Name: THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
• Type of Device: VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.
• MDR Report Key: 18347173
• MDR Text Key: 330878455
• Report Number: MW5149325
• 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 Catalogue 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): Required Intervention; Hospitalization
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White