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

Catalog Number 9392221

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

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 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
• 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: 8747166
• MDR Text Key: 149620542
• Report Number: 1030489-2019-00684
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00613994676597
• UDI-Public: 00613994676597
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100976
• 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: 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
• Device Operator: Health Professional
• Device Catalogue Number: 9392221
• Device Lot Number: UM15E003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention