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

Catalog Number 9391341

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that patient with tumor in l3 underwent posterior spinal fusion at l1-5, total end block spondylectomy and replacement of vertebral body at l3 in which spinal instrumentation was implanted.It was reported that on unknown date, post-op, autograft bone (iliac) and implant backed out and the autograft bone moved to the direction of spinal canal and it gave a pressure on dura mater.Dura mater was compressed.A revision surgery was performed on (b)(6) 2017.During the revision surgery, implant was removed and autograft bone which had already been implanted in the patient's body was shaved again and fibula was ingested then it was implanted at l3.Infection was suspected.Surgeon commented that " the size of iliac bone or the way its trimming may have caused the event.".

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6383044
• MDR Text Key: 69203049
• Report Number: 1030489-2017-00470
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00613994676467
• UDI-Public: 00613994676467
• 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,Followup
• Report Date: 02/08/2017

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: 9391341
• Device Lot Number: UM13H060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: 02/08/2017
• Supplement Dates FDA Received: 09/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2013
• 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