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

Catalog Number	436120B
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Pre op diagnosis: vertebral body burst fracture procedure performed: l2 replacement of vertebral body, t12-l4 posterior pps levels implanted: l2 posterior t12-l4 post op, the cage, which was inserted about 2 weeks ago, backed out after the operation.The extent of backing out was unknown.Re-operation was performed in which the cage that has backed out was replaced with t2).The posterior side has been fixed with v4, and the anterior vertebral body replacement was performed after the posterior fixation.The cage on the cranial side was placed in the direction of the adjusting end cap.
Additional Manufacturer Narrative
B5: additional information provided regarding the event.H3: product analysis found that visual and optical inspection revealed the centerpiece was returned missing the body setscrew.The inner thread crest where the body setscrew is threaded has also been damaged.The centerpiece implant can not hold its position without the setscrew.Unable determine root cause of implant backing out.H6: analysis resulted in change in eval.Code method, eval.Code result, and eval.Code conclusion.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.
Event or Problem Description
Patient demographics: gender- female pre op diagnosis: vertebral body burst fracture procedure performed: l2 replacement of vertebral body, t12-l4 posterior pps levels implanted: l2 posterior t12-l4 implant date: (b)(6) 2020; explant date: (b)(6) 2020 (planned) device status: explant planned it was reported that post op, cage backed out.The cage, which was inserted about 2 weeks, backed out after the operation.The extent of backing out was unknown.It was planned to perform a reoperation on (b)(6) 2020 (plan to remove the cage that has backed out and replace it with t2).The posterior side has been fixed with v4, and the anterior vertebral body replacement was performed after the posterior fixation.The cage on the cranial side was placed in the direction of the adjusting end cap.Patient complications were unknown.The cage backed out after the operation, so hospitalization was prolonged for the revision surgery.In revision surgery performed t2 stratosphere was removed and was replaced with t2 altitude.There was patient complication occurred which need to perform a re-operation.It seemed that the cage had been placed with the upper level disc remaining.Update received on through image on 03 jul 2020: end cap attached to the head and tail side, self-adjusting end cap fixed, returned with the center piece set screw removed, damage to the center piece set screw hole threads and burrs, and damage to the center piece set screw threads.

• 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: 10216971
• Report Number: 1030489-2020-00768
• Device Sequence Number: 11401010
• Product Code: MQP
• UDI-Device Identifier: 00643169634855
• UDI-Public: 00643169634855
• 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
• Report Date (Section B): 10/20/2020

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: 436120B
• Device Lot Number: CA19C074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 10/21/2020
• 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: Hospitalization; Required Intervention