MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ANCHOR 12MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 203H0012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/04/2023

Event Type  Injury  

Event Description

It was reported that the patient's left ureter was damaged during a tether procedure.It is not clear when this occurred, as it was not immediately noticed.Post-operatively, the subject had increased output from their chest tube, and urology was consulted.They performed creatinine levels on the output from the chest tube, and confirmed the ureter damage via ct scan.The patient was taken to the or to repair the damage.A nephrostomy bag was temporarily placed to alleviate pressure in the left kidney.There is a plan for stent placement in the left ureter around the repair site.The reporter also reported this event to fda via voluntary medwatch report mw5116753.This is report four of thirteen for this event.

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 3012447612-2023-00137 through 3012447612-2023-00149.

Manufacturer Narrative

H6: additional method code: 4109.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the products were not returned, however patient documentation was provided.Device evaluation could not be completed.The tether implants are unrefuted for involvement in a revision leading to patient harm.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient factors, operational factors, or surgical factors.Dhr review: dhr review unable to be performed as lot information is not known.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's left ureter was damaged during a tether procedure.It is not clear when this occurred, as it was not immediately noticed.Post-operatively, the subject had increased output from their chest tube, and urology was consulted.They performed creatinine levels on the output from the chest tube, and confirmed the ureter damage via ct scan.The patient was taken to the or to repair the damage.A nephrostomy bag was temporarily placed to alleviate pressure in the left kidney.There is a plan for stent placement in the left ureter around the repair site.The reporter also reported this event to fda via voluntary medwatch report mw5116753.This is report four of thirteen for this event.

• Brand Name: ANCHOR 12MM
• 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: 16876619
• MDR Text Key: 314640509
• Report Number: 3012447612-2023-00140
• Device Sequence Number: 1
• Product Code: CET
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024
• 2 Devices were Involved in the Event: 1 2

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: 203H0012
• Was Device Available for Evaluation?: No
• 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
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 12 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic