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

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 08/31/2018

Event Type  Injury  

Event Description

Surgery - for scoliosis a tether was placed from t4-t12 (thoracic vertebrae) for 125 degrees of scoliosis in a 14 yo (year old) girl.Partial disc excisions were performed from t4-t12 (thoracic vertebrae).This lead to a solid anterior and posterior fusion with a 95 degree scoliosis.The problem is not with the tether itself.There are 2 problems: 1) disc excisions should not be performed with tethers.This will lead to disc degeneration or as in this case a fusion.2) large curves should not be treated with a tether.Standard spine fusion and instrumentation would have highly likely led to a long-term successful outcome with one surgery.This child has now had 3 spine surgeries with a poor outcome and she needs more spine surgery.Surgery was performed on patient (b)(6) by dr.(b)(6) at (b)(6) hospital, (b)(6) on (b)(6) 2018 hist.No.(b)(4).

• Brand Name: TETHER
• Type of Device: VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER GMBH
• MDR Report Key: 17492512
• MDR Text Key: 320820508
• Report Number: MW5122829
• 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: Physician
• Type of Report: Initial
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White