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

Model Number	436113C
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
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 professional via manufacturer representative regarding a patient having spinal therapy due to cervical trauma.It was reported that once the cage has been mounted on the implant holder, its expansion was tested with the special butterfly handle without encountering any problems.Subsequently, inside the patient, the system seemed, however, to spin in circles, causing the cage not maintaining the expansion (as it collapsed after each turn).So cage was  immediately replaced with a new one.Once the new product was fitted, the system worked perfectly without any problems.There was no patient symptom reported.There were no further complications reported regarding the event.
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 professional via manufacturer representative regarding a patient having spinal therapy due to cervical trauma.It was reported that once the cage has been mounted on the implant holder, its expansion was tested with the special butterfly handle without encountering any problems.Subsequently, inside the patient, the system seemed, however, to spin in circles, causing the cage not maintaining the expansion (as it collapsed after each turn).So cage was  immediately replaced with a new one.Once the new product was fitted, the system worked perfectly without any problems.There was no patient symptom reported.There were 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: 13495746
• Report Number: 1030489-2022-00124
• Device Sequence Number: 4779388
• Product Code: MQP
• UDI-Device Identifier: 00643169634817
• UDI-Public: 00643169634817
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K183510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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: 436113C
• Device Catalogue Number: 436113C
• Device Lot Number: CA20D221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/09/2022
• 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: Male