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

Catalog Number 204H0300

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Spinal Column Injury (2081)

Event Date 06/29/2021

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 3012447612-2021-00243 through 3012447612-2021-00245.

Event Description

It was reported that a revision surgery was performed to remove a portion of a tether construct and to fuse since the patient's curve progressed.During the revision, the set screws were found to be cross-threaded and the cord was loose in the lumbar region.A previously-implanted competitive pedicle screw construct was extended an additional level during the revision.This is report one of three for this event.

Manufacturer Narrative

Device evaluation: product was not returned and photos were not provided.Device evaluation could not be completed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown operational factors, patient factors, or post-op events.Dhr review and related actions: dhr review could not be performed as lot numbers are not known.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that a revision surgery was performed to remove a portion of a tether construct and to fuse since the patient's curve progressed.During the revision, the set screws were found to be cross-threaded and the cord was loose in the lumbar region.A previously-implanted competitive pedicle screw construct was extended an additional level during the revision.This is report one of three for this event.

• 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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12158216
• MDR Text Key: 261427996
• Report Number: 3012447612-2021-00243
• Device Sequence Number: 1
• Product Code: QHP
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 204H0300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2021
• 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): Hospitalization; Required Intervention