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

Catalog Number	436120C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fracture.Product was not 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
It was reported that the patient underwent vertebral body anterior replacement at l2 due to compression fracture of vertebral body.Post-op, it was found that the cage has backed out by checking x-ray image after 2 weeks of operation.The patient was able to walk with a cane and there was no health damage in the patient at this point.However, it was checked by image that the extended endcap has contacted with the kidney and it was forecasted that serious damage will occur if the cage contacts with the anterior major blood vessel.Bone quality was very bad.It was found by checking the x-ray image taken in the first week after the operation that the vertebral body of the most upper level fractured.Maybe the screw at l4 loosened.Hence an revision surgery performed on (b)(6) 2020 in which all of the screws on the posterior side were removed and to replace the screws with thick screws and after that, retrieve the cage which backed out to the anterior side and to insert autologous bone.
Additional Manufacturer Narrative
Radiographic image review result: ct images for vertebral corpectomy and posterior spinal instrumentation provided.Levels are unknown, appear to be thoracic lumbar.The anterior vertebral body graft has translated laterally out of the corpectomy defect and does not appear to be expanded to the correct height.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
D10, h3, h6 h6: product analysis results: visual and optical inspection of the centerpiece expander did not reveal any damage to the implant.Functional inspection with a sample 20/25mm inserter confirmed the implant was able to connect and engage, expand and close without any grinding or restrictions.Unable to determine cause of implant backing out.The implant appears to function as intended.No fault found.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: 9881752
• Report Number: 1030489-2020-00371
• Device Sequence Number: 11450719
• Product Code: MQP
• UDI-Device Identifier: 00643169634862
• UDI-Public: 00643169634862
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2020

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 Catalogue Number: 436120C
• Device Lot Number: CA19C075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/14/2020; 05/20/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/16/2020; 05/26/2020
• 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: Other; Required Intervention