MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 300MM VBT CORD; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 204H0300

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem Spinal Column Injury (2081)

Event Date 03/28/2023

Event Type  Injury  

Event Description

It was reported reported a revision surgery was performed to address curve progression and suspected tether cord breakage.A posterior screw construct was added during the revision without removing the tether construct.This is report one of five for this event.

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.

• Brand Name: 300MM VBT CORD
• Type of Device: THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 19003520
• MDR Text Key: 338901476
• Report Number: 3012447612-2024-00058
• Device Sequence Number: 1
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068(17)230831(10)2966738
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H190005
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2023
• Device Catalogue Number: 204H0300
• Device Lot Number: 2966738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic