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

Catalog Number	9391326
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent spinal fusion surgery at t11/12 and l2/3 due to vertebral body collapse and pseudoarthrosis occurred to l1.Post-op, the patient fell from the bed at the 3rd day after the operation and also tumbled several times.The patient did not listen to the healthcare professional.The sinking and movement of t2, and the load to the screw occurred due to tumbling.Patient suffered pain in lumbar and back and prolonged hospitalization as a result of this event.The implanted cage was deviated from its position.Patient underwent revision surgery as a result of this event.In which, doctor adjusted the position of the cage, and the operation was completed.
Additional Manufacturer Narrative
Radiological image review results: post-op x-ray ct for anterior/posterior stabilization of l1 fracture.The anterior interbody graft is deviated and positioned into the interior vertebral body with little baseplate extent with the superior body no anterior fixation plate is present, the base plates appear undersized compared to the vertebral bodies and expanded height of the cage is taller than the corpectomy space.If information is provided in the future, a supplemental report will be issued.

• Brand Name: T2 ALTITUDE EXPANDABLE CORPECTOMY SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8784038
• Report Number: 1030489-2019-00750
• Device Sequence Number: 1707739
• Product Code: MQP
• UDI-Device Identifier: 00613994676481
• UDI-Public: 00613994676481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9391326
• Device Lot Number: UM15E002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 80 YR