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

Catalog Number 436120C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

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 Description

Patient demographics: gender-female, pre-operative diagnosis: trauma, procedure: anterior fixation levels, implanted: l2 device, status: implanted-remains in service.Implant date: (b)(6) 2019.It was reported that the patient underwent anterior fixation due to trauma.Post-operatively, the self-adjusting end cap moved and the cage migrated.After posterior fixation was performed, the alleged cage was placed the next week.The self-adjusting end cap was inserted in a free state and the final tightening was performed following the surgical technique.At a later date, it was pointed out that the cage has migrated to the approaching side and the angle of the self-adjusting end cap has changed as well.The extended end cap of 45mm was used.There were no patient complication occur as a result of this event.

Manufacturer Narrative

Radiographic image review result: post-op x rays for t12-l3 psi with l2 corpectomy performed by report.An ap view and single ct coronal slice are provided.The corpectomy cage is translated laterally which would be surprising if it was placed after the posterior instrumentation was already placed.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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9519163
• MDR Text Key: 177987044
• Report Number: 1030489-2019-01482
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00643169634862
• UDI-Public: 00643169634862
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

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 Catalogue Number: 436120C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1