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

Model Number 436025D

Device Problems Break (1069); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2023

Event Type  malfunction  

Event Description

Information was received from a healthcare provider (hcp) via a medtronic representative regarding a patient who was implanted with a centerpiece.It was reported that set screw in the implant was backed out to ensure no difficulty to expansion before loading the implant on the inserter.The implant was loaded it on the inserter.Expansion was tested and collapsed it again before implantation.When the cage was in position, it didn¿t expand.After a bit of force was applied to the t-handle, cracking sound was heard.The cage was removed and it was found broken.The event occurred in the patient table after the device was placed in position.Implantation and explantion was during the same surgery on 26th march.Pre-op diagnosis for the patient was fracture of t12/ corpectomy of t12.There was no revision surgery occurred in this event.No adverse event occurred to patient.There were no further complications that were reported.

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.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
• 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: 16795040
• MDR Text Key: 313850903
• Report Number: 1030489-2023-00298
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00643169663244
• UDI-Public: 00643169663244
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2023

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
• Device Operator: Health Professional
• Device Model Number: 436025D
• Device Catalogue Number: 436025D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2023
• Initial Date FDA Received: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male