MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK T2 ALTITUDE EXPANDABLE CORPECTOMY SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Literature citation "h.Tashi, a.Yamazaki, t.Izumi and t.Mizouchi" , "early stability for open door laminoplasty by using the cervical plates" ,average age: 60.4 years, 34 patients (28 males and 6 females) neither the product nor applicable imaging films were returned to manufacturer for evaluation.

Event Description

It was reported in an abstract that 34 patients (92 lamina) underwent laminoplasty with cervical plate from 2014 nov to 2015 mar.6 months post op ct of lumbar spine was performed which showed 4 screws protruded facet joints.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: T2 ALTITUDE EXPANDABLE CORPECTOMY SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5649459
• MDR Text Key: 44999632
• Report Number: 1030489-2016-01365
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

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: 04/14/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: 04/14/2016
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 60 YR