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

Model Number	436120A
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a cage implanted in a patient during a t12 subtotal removal, vertebral body replacement for a burst t12.It was reported that when the inserter was attached and the operation was checked before inserting it, the first cage did not extend.After removing and attaching the first cage from/ to the inserter several times and checking the operation repeatedly, it extended sometimes, but the condition did not improve because it got stuck in the middle or it did not extend unless a considerable amount of force was applied.The first cage was inserted into the patient's body once but it did not extend when an attempt was made.The first cage did not expand properly.Therefore a new cage was taken out.When an operation check was performed in the same way, the second cage extended somewhat, but still got stuck in the middle of extension.It suddenly became capable of extension when it was inserted into the patient's body.The installation of the second cage itself was completed without any problems or impact to the patient.The inserter was suspected as one possible cause.The event was associated with a patient.There were no symptoms or complications as a result of this event.This event was not a repeat surgery, there was a delay of less than 60 minutes in the overall procedure time, the patient did not need to be hospitalized or stay longer, and there was no treatment or additional surgery performed as a result of this event.The date of implant for both cages was (b)(6) 2022 and date of explant for the first cage was (b)(6) 2022.No further complications were reported/ anticipated.

• 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: 13658062
• Report Number: 1030489-2022-00205
• Device Sequence Number: 1944611
• Product Code: MQP
• UDI-Device Identifier: 00643169634848
• UDI-Public: 00643169634848
• 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): 03/03/2022

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: 436120A
• Device Catalogue Number: 436120A
• Device Lot Number: CA19C073
• 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: 02/10/2022
• Initial Report FDA Received Date: 03/03/2022
• 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