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

Catalog Number	9392221
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-ray review results: thoracolumbar fusion of burst fracture ct images and x-rays were provided.Anterior interbody graft appears to have subsided into lower vertebral body and superior vertebral body and now sets at an angle.Posterior instrumentation appears intact.It is not clear if the cage is at all collapsed from its initial configuration the rod appears straight.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 underwent vertebral column resection at t10-l2.Bone quality of the patient was reported as poor.Post-op, the screw placed at l1-l2 loosened; due to which the cage became unstable and inclined.The patient also experienced pain.Hence, a revision surgery was performed and the loosened screw was removed and replaced with a bigger screw.The fusion was also extended to l4 and the cage position was adjusted.The pain disappeared after the revision surgery.

• Brand Name: T2 SPINAL 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: 8747166
• Report Number: 1030489-2019-00684
• Device Sequence Number: 1669014
• Product Code: MQP
• UDI-Device Identifier: 00613994676597
• UDI-Public: 00613994676597
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2019

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: 9392221
• Device Lot Number: UM15E003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 07/01/2019
• 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