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	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
Levels implanted: l3-5 it was reported that the patient underwent replacement of l4 vertebral body due to pseudoarthrosis occurred after the vertebral body fracture at l4.Osteotomy on the contralateral side was not done enough during cage placement, so cage placement was performed near the approaching side.Although the surgeon also acknowledged that the osteotomy was not done enough, the operation was completed as it was.Post-op, on (b)(6) it was found by checking images during the two stage surgery of posterior fixation that 90% of the cage backed out.It was presumed that the cage backed out during the period from (b)(6) (after the operation) to (b)(6), and the anterior side of lumbar spine opened and the cage backed out when the patient was in supine position.It was planned to perform osteotomy on the contralateral side again and to place the cage from the anterior side on (b)(6).Device has been removed from the patient body in the revision surgery.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Cage replacement was performed during the revision surgery, and revision surgery was completed without any problem.No health damage in the patient was reported.
Additional Manufacturer Narrative
Product analysis results: after loosing the body set screw and functionally testing this centerpiece, it does not appear to be damaged nor does it indicate any functional issues.There was no fault found.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: 9590066
• Report Number: 1030489-2020-00064
• Device Sequence Number: 11574293
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2020

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: CA19C046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 03/30/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/12/2020; 04/23/2020
• 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: 70 YR