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

Catalog Number	436120C
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Confusion/ Disorientation (2553)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse event: other: fracture, delirium symptoms.Neither the device nor films of applicable imaging studies were 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 presented with l1 pseudoarthrosis; and underwent replacement of vertebral body by anterior approach.Placement of cage was performed at l1 in the first stage surgery; and oblique lumbar interbody fusion was performed at l2-l3.No complications or malfunctions were reported after this surgery.The second stage of surgery was to be performed on (b)(6) 2019.On the weekend after the first stage surgery, it was reported that the patient kicked the nurse with severe symptoms of delirium.In the morning of (b)(6) 2019, the surgeon was worried and x-rays taken before the operation revealed that the cage sank towards l2 endplate and the superior endplate of l2 fractured.There was a possibility that the l2 superior endplate got fractured because of the cage back-out.Bone quality of the patient was weak.It was unknown exactly what the cause was, but it seemed that the angle of the self-adjusting end cap had changed.Since it was not a major back-out, only the second stage surgery was performed (as it was planned).Posterior fixation was performed at t10-l4.Follow-up observations were planned for the patient.At the end of (b)(6), no further back-out of the cage has been reported.

• Brand Name: T2 STRATOSPHERE 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: 9689209
• Report Number: 1030489-2020-00162
• Device Sequence Number: 3320116
• Product Code: MQP
• UDI-Device Identifier: 00643169634862
• UDI-Public: 00643169634862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183510
• 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
• Report Date (Section B): 02/10/2020

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: 436120C
• Device Lot Number: CA18J204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/10/2020
• 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
• Patient Age: 86 YR