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

Model Number	436025C
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2020
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 provider via manufacturing representative regarding patient with unknown indication for spinal therapy.Event occurred intra-op.It was reported that issue occurred while attempting to implant the device.The implant was correctly loaded onto the inserter, and while implant was collapsed, biologic was packed into the center of the cage.Osteocell and ifactor mixed together for biologics.While inserting, it was attempted to expand the implant and seemed to jam.It was attempted to rotate t-handle inserter to expand, and it continued to jam.Implant was taken out and cleaned teeth and rotating mechanism.Biologics got caught in the teeth and jammed it.After many attempts to clean out the biologic and get it to expand, it continued to jam.On closer inspection, when it jammed, 2 teeth of the expansion mechanism had sheered off, and it would not expand without those.No patient symptoms or further complications reported.Device will be returned.Update; procedure was l4 corpectomy, approached anterior.
Additional Manufacturer Narrative
H3: device evaluated summary: visual and optical inspection confirmed a couple of the teeth in the centerpiece track have been stripped and broke off.It appears the teeth were overloaded from excessive force placed on the cage during use.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
• MDR Report Key: 11086072
• Report Number: 1030489-2020-01870
• Device Sequence Number: 16945708
• Product Code: MQP
• UDI-Device Identifier: 00643169663237
• UDI-Public: 00643169663237
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 436025C
• Device Catalogue Number: 436025C
• Device Lot Number: CA18J072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2020
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR