MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW VBT ASSY, 6.0MMX32.5MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 211H6032

Device Problem Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/04/2023

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 3012447612-2023-00150 through 3012447612-2023-00151.

Event Description

It was reported that a tether revision surgery was performed to address overcorrection of the compensatory curve.The screws were removed from t11 and t12 and the cord was released between t9 and 10 on the patient's right side.An additional tether construct was placed on the patient's left side from t11 through l4 during the procedure.This is report three of three for this event.

• Brand Name: SCREW VBT ASSY, 6.0MMX32.5MM
• 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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16876815
• MDR Text Key: 314641590
• Report Number: 3012447612-2023-00152
• Device Sequence Number: 1
• Product Code: CET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H190005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211H6032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 68 KG