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 02/14/2020

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Radiographic image review result: three images provided for l2 corpectomy with anterior instrumentation and l1-l3 posterior stabilization.The first ap x-ray shows the interbody cage translated out of the corpecting defect.The second image shows the endcap not in contact with the l1 interior end plate.The third image shows contact with the end plate.It is probable that the cage chipped and lost contact with the endplates along it to translate laterally.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent anterior vertebral body replacement at l2 due to burst fracture.Post-op, t3 backed out after it was inserted.Hence on (b)(6) 2020, during revision surgery, a patient position was taken and it was confirmed by checking the image that the implant has not been in contact with the endplate on the cranial side at all.It was performed after posterior fixation.The reason considered for backing out were the posterior screw loosened, and the anterior side opened.The t3 shrank after the operation.The third image was the image that was taken immediately after the operation.The frontal image right after the operation was not available, but it was considered that the position where the cage was placed had deviated a little from the center of the vertebral body.It was found that it has turned to the state of the first image three or four days after the initial surgery.The second image was taken during the revision surgery.When the implant was placed for the first time, it is unknown at this point that the implant has shrunk or the adjustable end cap was deviated.According to surgeon may be l3 had have compression fracture(it was unknown when compression fracture occurred).The product has been replaced with another implant on (b)(6).There were no other patient complications as a result of this event.

• 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: 9822049
• MDR Text Key: 188475189
• Report Number: 1030489-2020-00299
• 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
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 436120C
• Device Lot Number: CA18J204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR