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

Catalog Number	9391341
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.".
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6383044
• Report Number: 1030489-2017-00470
• Device Sequence Number: 10770557
• Product Code: MQP
• UDI-Device Identifier: 00613994676467
• UDI-Public: 00613994676467
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 9391341
• Device Lot Number: UM13H060
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 09/30/2017
• 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