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 Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review results: level unknown, thoracic fracture dislocation treated with altitude expandable cage.Pre-op, intra-op, post-op, post-op revision films provided.Initial construct looks ok though superior foot plate not entirely contacting vertebral body endplate, and cage in posterior part of intervertebral space.Failure ct shows anterior translocation of upper spine.Suspect given posterior column injury, 360 degree fusion was indicated for initial procedure.Root cause: patient factors, surgical technique.

Event Description

It was reported that the patient underwent an unspecified procedure.Post-op the implant was found migrated.The product came in contact with the patient.The patient underwent revision surgery on (b)(6) 2016.Patient complications were unknown.

• 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: 5942329
• MDR Text Key: 54396132
• Report Number: 1030489-2016-02527
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2016

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/12/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention