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

Model Number	9391316
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	05/19/2021
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
Information was received from healthcare professional via field representative regarding patient with symptoms of l1 compressed fracture involved in t11-l3 posterior fusion (l1 subtotal removal).Levels implanted: t11-l3.It was reported that on (b)(6) 2021, a patient with a compression fracture of l1 underwent subtotal resection of l1, replaced the ve rtebral body with the cylinder, and performed posterior fixation up to th11-l3.At that time, a bone fragment (autologous bone) was filled as a bone to be transplanted.Postoperatively, left leg pain occurred, and mri imaging confirmed a fracture of the end plate.It is unknown when the fracture occurred in the final stages.A piece of bone implanted as a transplanted bone protruded posteriorly, causing leg pain, and reoperation was performed on (b)(6) 2021.In the reoperation, t2 was not explanted, the bone fragment protruding posteriorly was removed, and the operation was completed.The bone fragment was an autologous bone implanted as a transplant bone.The leg pain was caused by a piece of bone protruding posteriorly at implanted level (l1).Fracture of the endplate occurred.The fracture of the end plate does not seem to be the cause of leg pain.Reported product was not explanted in the revision surgery.Additional decompression was performed as a result of this event.Event was associated with the patient and there was health damage on the patient.Product was used correctly according to the directions given in the ifu/labeling.

• Brand Name: T2 ALTITUDE 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: 11997721
• Report Number: 1030489-2021-00789
• Device Sequence Number: 3402253
• Product Code: MQP
• UDI-Device Identifier: 00613994676511
• UDI-Public: 00613994676511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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 Model Number: 9391316
• Device Catalogue Number: 9391316
• Device Lot Number: UM15D002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/15/2021
• 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