MAUDE Adverse Event Report: COLIGNE AG TRABIS [K173893]; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE- CERVICAL

Device Problem Migration (4003)

Patient Problem Arthritis (1723)

Event Date 11/28/2018

Event Type  Injury  

Event Description

Clinical literature cawley, derek t., et al "carbon-fibre cage reconstruction in anterior cervical corpectomy for multilevel / cervical spondylosis: mid-term outcomes." journal of spine surgery (2019) reports 102 human subjects underwent cervical corpectomy utilizing trabis k173893; 28.6% clinically significant device-related subsidence, 25.4% adjacent-level segment degeneration.Three revision surgeries, five device migrated requiring revision surgeries.Five failed outcomes pseudoarthrosis.During study period, device was not fda approved for cervical indications.Collectively, there were five pseudarthrosis cases where dynamic radiographs displayed >2 mm spinous process differences.Fda safety report id# (b)(4).

• Brand Name: TRABIS [K173893]
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE- CERVICAL
• Manufacturer (Section D): COLIGNE AG
• MDR Report Key: 8545900
• MDR Text Key: 143211373
• Report Number: MW5086113
• Device Sequence Number: 1
• Product Code: PLR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/20/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 77