MAUDE Adverse Event Report: ZIMMER GMBH THE TETHER; VERTEBRAL BODY TETHERING SYSTEM

Model Number 204H0300

Device Problems Use of Device Problem (1670); Output Problem (3005)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/04/2023

Event Type  Injury  

Event Description

During the implantation of the device, the patient's left ureter was damaged.It is not clear when this occurred during the procedure, as this damage was not immediately noticed.There were no complications noted during the procedure.Post-operatively, the patient had increased output from her left chest tube, resulting in the thoracic surgery team to consult urology for further evaluation.The patient's creatinine levels of the chest tube output was analyzed and found to be 19.42mgdl (no ref.Range).The damage to the ureter was confirmed by ct urography, with findings stating, "there is disruption of the left ureter at the level of l3 vertebral body with extravasation and pooling of contrast into the inferior perirenal space".Following these findings, the patient was taken to the operating room by the urology team on (b)(6) 2023 for the following procedures: cystourethroscopy, left retrograde pyelogram, attempted left ureteral stent placement, and left ureteroscopy.After unsuccessful attempt at stent placement, the patient was taken to interventional radiology for nephrostomy tube placement.The patient's chest tube output decreased, and the chest tube was able to be removed with no complications.The patient discharged on (b)(6) 2023, and will return to the or at the end of (b)(6)/early (b)(6) for stent placement in the left ureter.This event was reported to the manufacturer via product experience report (b)(4).

• Brand Name: THE TETHER
• Type of Device: VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER GMBH
• MDR Report Key: 16763396
• MDR Text Key: 313583593
• Report Number: MW5116753
• Device Sequence Number: 1
• Product Code: QHP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/13/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 204H0300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White