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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
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
Patient demographics: gender-female, pre-operative diagnosis: trauma, procedure: anterior fixation levels, implanted: l2 device, status: implanted-remains in service.Implant date: (b)(6) 2019.It was reported that the patient underwent anterior fixation due to trauma.Post-operatively, the self-adjusting end cap moved and the cage migrated.After posterior fixation was performed, the alleged cage was placed the next week.The self-adjusting end cap was inserted in a free state and the final tightening was performed following the surgical technique.At a later date, it was pointed out that the cage has migrated to the approaching side and the angle of the self-adjusting end cap has changed as well.The extended end cap of 45mm was used.There were no patient complication occur as a result of this event.
Additional Manufacturer Narrative
Radiographic image review result: post-op x rays for t12-l3 psi with l2 corpectomy performed by report.An ap view and single ct coronal slice are provided.The corpectomy cage is translated laterally which would be surprising if it was placed after the posterior instrumentation was already placed.If information is provided in the future, a supplemental report will be issued.

• 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: 9519163
• Report Number: 1030489-2019-01482
• Device Sequence Number: 418339
• 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,Followup
• Report Date (Section B): 02/20/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 436120C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1