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

Model Number 436120B

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Information was received from healthcare professional via field representative regarding patient with unknown indication involved in the reported event.Levels implanted: t10-l5.It was reported that they performed vertebral body replacement and posterior fusion of t11.12.L2 for l1 burst.After that, the t3 vertebral body replacement cage sunk to the l2 vertebral body, and at the same time, the l2 screw backed out.The l2 screw was removed and since there was bkp in l3, screw was added to l4.5 and t10 to extend and re-fixed.There was no malfunction with the products.Patient symptoms- dorsal pain was reported.Patient was hospitalized prolong as a result of this event.

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.

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.

Event Description

Information was received from healthcare professional via field representative regarding patient with unknown indication involved in the reported event.Levels implanted: t10-l5.It was reported that they performed vertebral body replacement and posterior fusion of t11.12.L2 for l1 burst.After that, the t3 vertebral body replacement cage sunk to the l2 vertebral body, and at the same time, the l2 screw backed out.The l2 screw was removed and since there was bkp in l3, screw was added to l4.5 and t10 to extend and re-fixed.There was no malfunction with the products.Patient symptoms- dorsal pain was reported.Patient was hospitalized prolong as a result of this event.On (b)(6) 2022, received additional information that since it was set on 20mm b, endcap part was sunk.There is no plan for revision surgery to explant the cage and endcap.It was reported that probably, dorsal pain caused due to cage/endcap sunk or due to screw back out.The current state of the product could not be confirmed because they are inside the body.

• Brand Name: T2 STRATOSPHERE¿ EXPANDABLE CORPECTOMY SYSTEM
• Type of Device: 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: 13168723
• MDR Text Key: 288997878
• Report Number: 1030489-2022-00018
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00643169634855
• UDI-Public: 00643169634855
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 436120B
• Device Catalogue Number: 436120B
• Device Lot Number: CA19C074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male