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

Model Number	436120C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for vertebral body replacement (anterior approach).The pre-op diagnosis was mentioned as l1 vertebral fracture.It was reported that, implant back-out is being confirmed after the surgery. upon checking the image, it seems that the self-adjusting endo cap on the upper end plate side of l2 is moving despite the final tightening.The cage was dislocated approximately 1 week after the procedure.It seems that the endo cap is moving.The end plate is fractured.The levels implanted were l1. no revision surgery is planned to explant.There was no symptoms or complications reported.There was no additional treatment or surgery performed as a result.No further complications reported regarding the event.

• 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
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14546717
• Report Number: 1030489-2022-00511
• Device Sequence Number: 6633720
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

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 Model Number: 436120C
• Device Catalogue Number: 436120C
• Device Lot Number: CA20B054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/31/2022
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female