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

Catalog Number	9391633
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Disability (2371); No Code Available (3191)
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
Pre-operative diagnosis: burst fracture type of procedure: anterior fixation posterior fixation levels implanted: l2, l1-l3 it was reported that on unknown date, post-op, posterior fixation of l1-3 and anterior fixation of l2 were performed for burst fracture of l2.During anterior fixation, t2 and iliac bone were placed.After the operation, cage at t2 backed out and revision surgery was performed at posterior part on (b)(6) 2018.In the opinion of the physician, there was no fall down etc.But it was considered that t2 backed out because of t2 installation position at first and severe osteoporosis.According to the healthcare professional's opinion, patient symptoms or complications result in disability.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7724695
• Report Number: 1030489-2018-01061
• Device Sequence Number: 11029139
• Product Code: MQP
• UDI-Device Identifier: 00613994676412
• UDI-Public: 00613994676412
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 9391633
• Device Lot Number: UM14H010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Other; Required Intervention