MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VBT SCREW, UNKNOWN SIZE; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 211HXXXX

Device Problem Mechanical Problem (1384)

Patient Problem Spinal Column Injury (2081)

Event Date 10/23/2022

Event Type  Injury  

Manufacturer Narrative

Procode: qhp.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.Reference reports 3012447612-2022-00307 through 3012447612-2022-00310.

Event Description

It was reported that the patient underwent a posterior spinal fusion with lumbar vertebral tether.Upon her standing x-ray on pod 3, it was noted to list off at the l2-l3 and l3-l4 vertebra.Previously during the implant surgery, there was concern of over correcting her lumbar curve.In turn, the slack at the l2-l3 segment allowed for translation and a 33-degree curve.After discussion with the family, including the risks, benefits, complications, and alternatives, the decision was made to proceed with a revision to retighten the tether l2-l4.After retightening the tether, the curve improved to 25 degrees.This is report two of four for this event.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the products were not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to patient, surgeon, or surgery specific factors.Dhr review: the lot numbers were not provided, so the dhrs were unable to be reviewed.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that the patient underwent a posterior spinal fusion with lumbar vertebral tether.Upon her standing x-ray on pod 3, it was noted to list off at the l2-l3 and l3-l4 vertebra.Previously during the implant surgery, there was concern of over correcting her lumbar curve.In turn, the slack at the l2-l3 segment allowed for translation and a 33-degree curve.After discussion with the family, including the risks, benefits, complications, and alternatives, the decision was made to proceed with a revision to retighten the tether l2-l4.After retightening the tether, the curve improved to 25 degrees.This is report two of four for this event.

• Brand Name: VBT SCREW, UNKNOWN SIZE
• 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: 16000291
• MDR Text Key: 305683308
• Report Number: 3012447612-2022-00308
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

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: 211HXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 9 YR
• Patient Sex: Female
• Patient Weight: 65 KG