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

Model Number	436013A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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
Information was received from a consumer via field representative a patient who undergone spinal therapy with unknown indication.It was reported that the inserter lock doesn¿t work correctly and gets stuck.Removal tool tip was bent while trying to remove an endcap and centerpiece would not expand when met with resistance in the disc space.No patient symptoms or complications associated with this event.The case was a c6 corpectomy and the consumer wanted to use stratosphere.There was surgical delay of 45 minutes due to reported product malfunction.No further complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection of the centerpiece expander revealed the gears/teeth have been damaged and broken.Functional inspection with a sample 13mm inserter confirmed the implant was able to connect and engage but unable to open smoothly and collapse.The issue appears to be where the tip of the expansion shaft contacts the teeth and cage of the centerpiece when the expansion shaft is inserted and turned.Per the print 436120a-e on note 7 rev-c, with the locking set screw backed out, the assembly must be able to smoothly expand and collapse.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
• 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: 11249730
• Report Number: 1030489-2021-00111
• Device Sequence Number: 14335953
• Product Code: MQP
• UDI-Device Identifier: 00643169663114
• UDI-Public: 00643169663114
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 436013A
• Device Catalogue Number: 436013A
• Device Lot Number: CA18M002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1