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

Model Number	4360308
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l5 corpectomy f rom an anterior approach.It was reported that stratosphere cage was placed with a pyramid 3 hole plate placed at the promontory of s1.After this stage patient was flipped to prone and a l2-il procedure was performed using solera mas screws and ballast cmas screws. there were no further complications reported regarding the event.Additional information was received: pre-op diagnosis/medical history: l5 burst fracture procedure involved: l5 corpectomy with expandable cage placement from l4 endplate to s1 endplate.Plate implanted anteriorly at s1.The exposure surgeon in the room for the removal noted the patient acknowledged a fall after surgery (timeframe unknown).The front of s1 broke off causing the plate and 2 screws to break off the bone.The cage also kicked out anteriorly after this incident and at this point was not adding any structural support to the construct.The patient had posterior hardware in which all stayed intact.After the fracture at s1 and the hardware kicked out anteriorly the patient was no longer structurally supported up front.Implants had to be removed as they were close to the aorta and vena cava.The stratosphere cage and the plate and screws were removed.The surgeon then decided to support the void with bone cement and steinmann pins due to area of space available to work in.The plate and screws did not break.The bone on the front of s1 broke off with the plate and screws still attached.There was no malfunction with the plate and screws.The endcaps stayed intact with the cage and migrated forward when the cage kicked out.No specific injury occurred to patient but implants had to be removed due to where they were located after the implants kicked out anteriorly.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• 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: 15037666
• Report Number: 1030489-2022-00659
• Device Sequence Number: 5248667
• Product Code: MQP
• UDI-Device Identifier: 00643169651029
• UDI-Public: 00643169651029
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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 Model Number: 4360308
• Device Catalogue Number: 4360308
• Device Lot Number: UNKNOWN
• 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: 07/11/2022
• Initial Report FDA Received Date: 07/18/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 80 KG