MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM

Catalog Number	436120450
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient presented with kyphoscoliosis; and underwent anterior fixation and oblique lumbar interbody fusion at l1-l3 and vertebral body replacement of l4.From the third day after anterior fixation, the patient had been allowed to walk only when she went to the toilet.On checking the x-ray on the fourth day post-op, it was confirmed that the self-adjusting endcap was moving, due to which, the correction had returned a little.At the time of posterior fixation performed on (b)(6) 2019, a correction was tried to be performed again during compression from the posterior side.As the bone quality was poor, the correction rate was not good.No patient complications have been reported due to this event now.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The adjustable end cap had not been locked after final tightening.

• Brand Name: T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9517755
• Report Number: 1030489-2019-01478
• Device Sequence Number: 10877501
• Product Code: MQP
• UDI-Device Identifier: 00643169638426
• UDI-Public: 00643169638426
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 436120450
• Device Lot Number: CA18G034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 12/25/2019
• Supplement Report FDA Received Date: 01/31/2020
• 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: Required Intervention
• Patient Age: 62 YR